How to build your State-of-the-art for your Clinical or Performance Evaluation?

How to build your State-of-the-art for your Clinical or Performance Evaluation?

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welcome to the medical device made  easy podcast here is Monir El Azzouzi   from easymedicaldevice.com and today we will  help you understand something that is called   sota so sota but it's also called state of the art  so we talk a lot about that during uh within the   mgr but we'll also talk about that for ivdr and uh  i have with me so hakan inan so managing director   at you quality uh with will help us to understand  how to build your sota or your state of the art   so hakan inan was a lot of help was talking  to us last time about performance evaluation   on the podcast and now he's coming back to  help us on the sota so hakan welcome to the   medical device made easy podcast hi thank  you thanks for having me glad to be back   great so yeah after last episode on  ivdr for performance evaluation i think   uh we needed uh still some some more information  about ivdr but the topic of today as we discussed   is not specifically ivdr but we can maybe uh  place some ivdr uh iv examples on it and so it   will be mainly about state of the art but um as  last time so can you make a small introduction of   yourself so that people that don't know you maybe  will have a better understanding of who you are   sure as you said i am hakan inan i am the  founder and managing director of re-quality   gambia it's a regulatory and quality company  located at munich germany we mainly provide medical device companies and  individual diagnostic companies   support in their performance and  clinical evaluation reporting   in compliance with mdr and ivdr good  so um as as we said so mainly you are   helping so other companies are as a consultant so  um so the topic of today will be state of the art   and as we said it's not specifically mdr it's  also ivdr so um if you had to explain that   to somebody that is coming to a state okay what is  state of the art what would you say to this person   yeah the topic itself is quite complex  actually um there are a couple of aspects uh   related to state of the art as a as a term uh  when you look at the regulation actually um   uh i was just going through the md rna video  regulation i just wanted to see how many   times this term was used okay and so in mdr so  state of the art as a term was used 12 times   12 12 times exactly and in ivdr in in vitro  diagnostic regulation it was used 20 times okay   wow yeah but here is the point Monir although it  has been mentioned quite some in both regulations   and there is no official definition for state  of the art okay so this is the strange part   so and as you know article number two in mdr and  ivdr uh lists the terms and dif definitions of   these terms yeah but in in uh none of them uh  you will find the state-of-the-art definition   so i suppose i suppose there will be then as usual  a lot of interpretation from anybody about what   is state of the art exactly so and this is this is  the main issue with the state of the art as a term   but we do have guidelines documents i mean luckily  we do have guidelines documents state of the art   is that is not a new term actually okay the term  the term was already there it was already used in   directives under directives and particularly for  clinical evaluation reporting state-of-the-art   was always used and utilized and when you look at  the med dev 2.71 revision 4 state of the art has   already been given there and normally let's let's  do one thing i mean when you say state of the art   to a lay person uh men generally state of thought  actually i just checked the uh the dictionary   definition the collins dictionary and oxfords and  other dictionaries define state-of-the-art now if   you define if you use state-of-the-art as um as  an adjective okay so if you say if you want to say   that what a state-of-the-art building what a state  or art factory what a state-of-the-art facility so   which means that the most advanced and uh uh you  know most technologically advanced place when you   use it as an adjective uh that's that's the common  main confusion actually but if you want to use   state-of-the-art as a technical term especially  in in context of ivdrm and mdr it is the level of   knowledge and development achieved by a technique  and within this science and the domain so it's   not uh necessarily the most advanced technique  and technology so this is a little bit confusing   for me for me when i try to explain that  to anybody it's more like what is existing   actually as of today on the market for a certain  disease or for a certain treatment or for certain   diagnosis or whatever so what are the different  techniques so what are the different technologies   that are existing and then we are making if i  can say just a review of all what is existing   uh on the market and then the objective i suppose  is that after that you take your technology and   you just put a cursor of where is your technology  against what is already existing on the market   yeah exactly so this is i think this is the  philosophy of the uh regulations so they   want to have a clear picture of what is already  present what is achievable what is more acceptable   and what can be achieved by most majority of the  devices that are already in the market so you need   to have you need to provide a clear and complete  picture of an entire scene you know so i think   it's a it's it's a very good approach that you  have said just uh moving into that before moving   into that i just wanted to mention a few other  issues that that is relevant to the the current   state-of-the-art term now uh and as you know there  are also um translations of our regulations yeah   and like so the state of the art as a term uh that  needs to be translated in every different official   language when you look at the german translation  of the ivdr there are certain confusions that you   can see that arises from the from the translation  actually because now the the german word for that   is the standard technique which is named as the  state of the art but when you go through the um   when you go through the uh the translation of  the ivdr especially so there are multiple places   where the german definition is more like uh the  most advanced and the latest medical technology   or latest medical knowledge so when you  compare to english version which is normally   just the state of the art so i think we will  we will have this issue of uh state of the   art and how to define state of the art for  coming years for some more time until we get   feedback from the uh notified bodies and so i i  suppose for example as i know that there is a lot   of notified bodies that are located in germany  in germany go to another country and try to   understand it from by reading the german part but  not really not really looking at the english part   you can have some issues if i can say just to  i mean what they will see is actually what they   will expect i suppose yeah exactly because when  you look at the german translation it says that   the latest medical in in certain places not in  every places it says that latest medical knowledge   but when you look at the state of the art as a  definition we know that it's not the it's not only   the latest medical knowledge it's just it can be  the things that they share it can be things that   happened 20 or 30 years ago that were created  since the beginning that are bad basic now that   uh if i can say are working well but uh but not  not new things so it's really uh exactly like like   hematology for instance some of the hematology  stains are on the market since like 50 60 years   and the state of the art is not changed a lot  within this content context you know but uh   anyway this is one thing that i i really would  like to mention before we move into the in the   english part so uh now although the state of  the art is not defined within the mdr and ivdr   we now have as you know actually just recently  mdcg guidelines we have mdcg guidelines on   antibody covid antibody tests for instance  that specifically details about the state of   the art in the antibody of it and by the tests  so the state of the art is in the name of the uh   the the report we also have um the recent  guideline actually when you look at this uh   mdcg 2021-5 which it just came out in april that's  related to the guidance on the standardization   and even in that document uh there  is a specific section section 3.5   it says that the concept of state of the art so  even within that document actually it says that the the state of the art is a  difficult concept to explain and it is a very complex and it needs to be   it needs to be uh treated as  such so when you look at it and it says specifically this mdc g20 21.5  specifically says that taking into account  

does not mean compliance so we have in many places  like in jsp rs we say that taking into account the   current state of the art but it's not although  it's it's a term it's not a a requirement for the   compliance but this has to be provided okay so  when you look at that it says that state of the   art is not legally defined concept and it all it  involves several complex aspects uh difficult to   be expressed in a single and clear definition okay  so actually when you look at the when you look   at the document mdcg 2025 2021.5 this is what is  given so is that means that it says that we give   that we give that to manufacturers and say okay  now do whatever you want with that it's correct so   we have luckily we have guidelines actually so the  state-of-the-art actually has been defined clearly   in imdrf documents as you know imdrf formerly  known as ghdf yeah you know international medical   device regulatories form now this there is wgn 47  document and within that document state-of-the-art   has been described and this definition  actually have been repeated in med dev document   and now we see that an uh recent clinical  uh evaluation uh uh guidelines document   that's been released by mdcg it's the same uh  definition has been taken so so we can see that   this this is the official definition coming from  the uh regulators so it says that develop staged   develop stage of technical capability at a given  time okay as a regards to products processes   and services based on relevant consolidated  findings of science technology and experience   and actually and there is a note there and this  node is follow up in in imdrf in med dev in   also other documents it says that the state of  the art embodies what is currently and generally   accepted as a good practice as you mentioned  in technology and in medicine so it has two   aspects here so it is relevant to the technology  but it's also relevant to the medicine   and the state of the art does not necessarily  imply the most technologically advanced   solution okay so the state of the art  exactly is state of the art is also generally   mentioned in many places as generally accepted  generally acknowledged state of the art so when   you look at the definition definition clearly  says that we are not looking at the most advanced   most used uh technology we are rather than we  are looking at a stat a status of the entire field where we are where we are developing our  our medical device and i suppose that we are   should we take into consideration only medical  devices or should be also taken into consideration   other forms of treatments like drugs or like  other other elements that can maybe exist like   atmp or whatever so are we focused on medical  devices or can we go outside of this scope   yeah i think this is important uh Monir that  what you're bringing up so uh it's not very clear   but what i would suggest so i mean what describes  the uh uh the field is our intended purpose if our   intended purpose is relevant to medical device and  a disease and a condition so i would suggest that   we stick with that okay because for instance if  you discuss about like a covid test and it's you   want to discuss about only a medical device but we  also know that there are lots of treatment options   such as the new drugs yeah but definitely this  is not in the scope of our uh state of the art   i mean you cannot compare you cannot compare your  device to this specific mode of action because   it's not the same mode of action so you cannot  just say my device can do this i can do that in   comparison to anything that can do this i can do  that mode of action yeah yeah exactly so i mean   what derives the state of the art for us is the  intended purpose and what's our intended purpose   describes the class and everything is you know and  so then uh it's better to stick within the uh uh   domain of the uh of the medical device and  what we claim okay you know so and unless if   you talk about companion diagnostic as you know  companion diagnostic always have an element of   uh therapeutics yeah but other than that i would  say we better stick on the uh on the field and   because now for as you know there is a medical  device aspect there is uh individual diagnosis   but there is also drug and therapeutics aspect  so yeah i think it will be so much to cover and   we will lose the scope yeah so um if we now now  that we have if i can see a better understanding   of the definition what it is and what is inside or  what we should have in scope so um do you have a   specific methodology to uh to start your creation  of your state of the art for your product or your   device so is there a specific steps to follow  here yeah i mean like of course um these are not   defined in anywhere but in so when you look at the  i mean where this state of the art should be given   now this is the first question i think we have  to ask if we are if we are manufacturer and we   want to provide technical file and where where  are we going to discuss about state of the art   you know in which document in which section so  when you look at the uh ivdr and mdr generally   state of the art is mentioned within the in  ivdr within the performance evolution planning   okay and and then performance evaluation report  and clinical performance study plan in ivdr   it's been specifically mentioned that you need to  provide information about state of the art within   these sections and when you look at the mdr mdr  is uh comparably uh mdr says that in within the   clinical evaluation plan and of course clinical  evaluation report and clinical investigation okay   so within these sections you'll have to describe  your uh state of the art when you look at the   ivdr monir as you know we have discussed this  before ivdr also has an element called the   scientific validity report yeah so scientific  valid is where we discuss all the scientific   background of the device intended purpose  and the the medical condition and the analyte   so a big state of the art the common  state of the art the main body uh   as per our understanding should be given under  scientific validated report within the context of   in vitro diagnostic regulation okay so  yeah we have to put in in terms of that so   as you said so this is the place where we are  having that i think the objective of that is   also that we we put it in in this place or  the clinical evaluation report or clinical   or performance evaluation because we have to  prove that our device is safe and performant   and against also what is existing around around it  so it's just to as i said to put the cursor of our   device where it is in comparison to what it is so  i suppose do we have also to make a comparison of   our products benefits risk ratio in comparison to  other solutions that are existing on the market   yes so this is an important aspect and now uh  coming to your first and second question let's   combine both of them now so what do we have to  discuss within the state of the arts section   you know what it should contain first of all uh  we we have to provide a background information   okay background information in terms of what is  the scientific background if you are measuring   an analyte let's say that i am measuring uh i  have a glucometer i have my device my device is   a glucometer so i have to provide first of all  scientific information scientific background   so i mean what i'm measuring i'm measuring glucose  so i have to provide information about glucose   and then what else medical background so i  and what is my disease that i am i'm trying to   i'm trying to diagnose or treat whatever what's  my whatever my purpose is so it's diabetes right   so i have to provide information about diabetes  what is the current background what is the   epidemiology what is the prevalence so now you  see we start from scientific reality biochemistry   of glucose let's say scientific background  and its function and then we move into the   disease and the condition so what is the disease  what is the epidemiology what's the current   status of the disease how many people are sick  with that disease you know what's the current   uh form of disease development and what's  the prevalence within the society so on and   so forth so second step providing medical  background information and the third step   is what are the current methods  and techniques that are utilized   so this is where you know we discuss about the  technique what is my what my technique is based on   is it an antibody test is it a genetic test is it  a blood based test so and what kind of technique   and technology i am using within there uh i'm  using am i using like a an amplification a genetic test or am i using an antibody test or am  i using a an automated system so and then   how does this compare to other  methods and techniques that are   you that are already there because we  will provide only one technique but   obviously in the market there are already  different technologies yeah it's already been   applied so and then after giving this background  information on techniques technologies and methods   for my disease for my analyte now the next  step is the comparison okay now so how does   my device perform in compared to other devices  performance is an important parameter miner   now in 2008 actually uh this there was one  of the hiv tests okay and the european union   has rejected application because this hiv  test was not state of the art based on the   low performance category oh yeah in compared to  in compared to other hiv tests in 2008 on that   day this device was providing a low uh was in the  low low tire and it's in compared to other devices   it lacks the performance uh elements so that's  why this has been rejected by notified body   actually this is an active actually it's an  interesting uh interesting point to consider so   performance is an important element  what describes performance of the device what is what is important one what you are saying  is that you doing this analyzes also of state of   the art and putting your device inside all  this information you have also to prove that   your device is better or is in the higher level  um sector if i can sell the state of the art   instead of the one that is really old uh product  that is maybe with more risk with less benefit   et cetera et cetera so you are also exactly trying  to prove that your device is doing good yeah right   to others yeah exactly so here we can say that  i mean we don't we don't need to prove that our   device is the best okay or better than others but  we just need to provide that our device achieves   what's what majority of the devices are already  achieving you know and it is comparable yeah   you know if they are providing a test result  within 10 days so then my device is also   providing device results in 10 days if they have  sensitivity of 90 percent on average my device is   already providing 1995 so i don't need to  prove that my device is better or the best   but i need to just provide a background  information and the the justification that   my device is also achieving these parameters  which are commonly and generally accepted   and acknowledged within the within the market  you know so so how do i do all that then all   these searches that we talked about the disease  the methodology the thing so should i go on   google and say okay diabetes what is diabetes uh  let's let me tell you more about that so what is   the methodology that we can do for for making the  search yeah this is important part now so we have   provided a scientific medical technical background  we also just i i don't want to miss that point   we also had to provide guidelines because now we  we have so many professional uh societies you know   they provide like they provide starting from who  to many uh disease uh related societies yeah so they provide guidelines documents and within  those guideline documents depending on the   techniques of course if the technique is  well established mostly you will find some   guidelines and within these guidelines you  already have some performance safety and   characteristic elements so we also use  those guidelines we see that i mean   these guidelines are already there according to so  and so guidelines these devices has to provide the   following information you know so this is one  thing we go from guidelines and then of course   literature search the most important thing so uh  is that so where do we get this scientific medical   and technical information most of the times we  we perform a systematic literature search so   we have to use databases and we have to utilize  those databases and we have to identify parameters   and most of those parameters are already  given so we'll have to we'll have to dive into   those scientific parameters and we  have to provide those information   for these for the scientists out there so i just  would say when scientists prepare a review article   so it provides all the information about the  current status within the field so it is like   preparing a review article and you provide all  the information and at the end you conclude   that whether you're your device your device of  interest is state-of-the-art or not okay you know   so that's how that's that's how you conclude  so so i think this is important because we   can also define that our device is not state of  the art so what does it mean at the end exactly   so here that's that's interesting because here  when you look at the regulation in many places   it says that it has to be like mainly  performance safety uh you know and and the risk   so when you look at these three elements it says  that based on current acknowledge state of the art   based off you know based off the state of  the art so as i said state of the art is   used in many places but how this will be treated  uh it's not clear but from the example that i have   just given you there is uh um there is a um  a decision based on state of the art actually   maybe i'll share this with  you so it is done in 2008   and the device was assumed not to be state of the  art so and device was rejected the application of   the manufacturer was rejected based on that yeah  so uh that's why it's a bit delicate issue not   very clear at the moment we are still expecting  guidelines and documents and also the the practical of course practical experience  will also tell us how notified bodies are   are treating the state of the art but i think it's  it's an important element it needs to be addressed   and in sections you will have in especially in  performance evolution and clinical evaluation   report you definitely need to provide  state-of-the-art and you have to mention   whether your device is state-of-the-art or not so  just maybe one clarification so in terms of state   of the art so uh if my device is a completely  new technology that was not existing at all   and that is completely disruptive technology  when you make the state of the art section you   will never find any of this type of devices inside  but maybe this device has less risk than any other   provides more performance than any other  etc can we say this device is state of the   art because it's not existing i mean like  here when you look at the regulation i mean   regulation always says that if you want to say  something or if you don't want to say something   you always have to justify okay you cannot  simply say that my device is state-of-the-art   or my device is not state-of-the-art so you will  have to prove this okay and as you mentioned new   and disruptive technologies novel technologies  although very rare but there will be very less   accumulated scientific and medical  knowledge so then you'll have to provide   already some performance if you have performance studies you definitely  need to provide performance studies then so   because the the the field is not developed as  to say so you need to provide those information   uh you need to have consensus  reports you need to have expert reports and you need to provide um consensus from the experts and also keep in  mind this will depend on the class of the device   so you may request require the amount of  scientific evidence might change but we definitely   you can utilize some of the analytical and  clinical performance data in your state of the art   yeah and and one thing that is important as  we mentioned as we have this discussion today   is about the fact that nothing is black or white  there is a lot of gray in the middle uh so even   if you think it's not state of the art if you  have maybe a good justification to be accepted   if you think it's state of the art but in  reality it has it is on the lower and uh if   i can say of the state of the art maybe it will  not be exited because the the risks are more   higher than other technologies and other things  so as you said there is nothing black or white   there is always gray so you have to provide some  justification provide some evidence have a debate   open with the regulators have the documentation  that are opening this debate and that are   providing your point of view because you are also  the one that knows better the device instead of   the other people that are doing that exactly  i mean this is this is i think very important   aspect so the uh you really need to uh have  justification for every claim that you have and   support it either scientifically from literature  search or from performance studies that your   device is state-of-the-art and just keep in mind  state-of-the-art sometimes is a very dynamic   yeah you know so for instance you have a  hematology device that you just want to   measure blood count it is a very well established  technology and it's been there for like 50 60   years maybe there is very very limited development  over the years with state of the art but just   imagine the case of the covid last year i mean  if you were to prepare a state of the art for   the covid a diagnostic test kit let's see  and last year there were no mutations exactly   no variance and you but now you came here your  state of the art has changed and you know the   life cycle of the device as you know the  performance evaluation uh clinical evaluations   according to the regulations now has to be kept  and updated throughout the life cycle of the   device so it means that depending on the class  you'll have to update yeah so it means that yeah   it's not something that you are creating once  it's something that you have to reevaluate   i don't know if it's every year every two  years or it definitely depends on your agenda   but you have to evaluate that frequently  so that you can confirm that your products   are state of the art i think for the mdr you  can use also the post marketing surveillance   pmcs also to get those data to confirm if you are  still uh if there is some new technologies new   competitors new products that are issued on the on  the market because yeah it's not like you say oh   today i'm state of the art everything is fine but  maybe in two or three or four years there will be   a big advance in this technology or in this  field and then you are not anymore state of   the art you are really on the lower hand and you  are you cannot justify anymore to be on the market   yeah exactly familiar now um so if let's say  that if you're a high-risk high-class group   in ivdr or mdr so you know that the you  need to update your reports annually   but if even if uh sometimes if a new state of the  art has appeared if the if there is a performance   or safety or state-of-the-art changes then you  don't need to wait annual reporting so you need to   update your report as soon as those are known  and understandable so that's that's i think the   case uh for low class uh devices um for like in  ivdr a and b you have to maintain throughout the   life cycle although the regulation does  not imply exactly whether you have to   update it every year or two once in two  years but still if there is a change   and update in in the state of the art that's  the definitive uh uh derive into your update   and your performance evaluation and as we all know  that clinical and performance evaluation is also   updated with the new findings from  post market service and vigilance there   yeah i think it's a it's a it's a good a good  summary here um in terms of state of the art so   um is there a specific skill or if i can say a  specific diploma that the person that is doing   that should have or anybody that is maybe trained  um with few hours of training on that can do it   hey our experience is that so uh it it is quite a  complex uh issue because you really have to have a   good understanding of uh science medicine field  medical field that you are applying your device   and regulations and you know  so and you should be able to read understand what is there on scientifically  and you should be able to evaluate those   so that you can write what is in those reports  so when you're thinking when you think of this   complex background uh i think a trained  person would definitely would be required   uh at least i mean with masters or phd degrees  in the within the field who can understand   what is scientifically there and what is in  the medical field so that they can they can   you know put together all this in a in a report  and just keep in mind that there is also a huge uh   brain power goes there and people need to need  to read evaluate and justify so many aspects so   to to to to put together a coherent story let's  put in this way so i would definitely say that   it requires advanced degrees in the field in  relevant fields because now medical field is you   know is also quite complex yeah i mean like there  is a field in cardiovascular and neuro neurology   so you have so many different fields and so  you definitely require advanced degree uh   and you also need a really good training yeah i  i i i can just confirm that from my side i mean   i had to work with many customers in terms  of clinical evaluation in terms of just also   creating the state of the art um the issue is the  fact that i'm not an expert in all the clinical   fields i know how to do that but uh give me  a 10 publication to read about that and uh   i will it will take maybe 100 hours for me to do  that and to try to imagine when maybe somebody   that is trying on this field it will take 10 hours  just to read and to understand the compile and to   then make its conclusion and whatever so so it's  true that yeah the issue we have as regulators   or as people that are really specialized on  quality and regulatory affairs is the fact that   we don't have this clinical aspect this clinical  knowledge of for some products and then uh even   if we have focused diplomas even if we have some  experience i'm a surgeon that is specialized in a   neurosurgery you cannot do uh heart surgery  maybe or cannot do an orthopedist because you   are specialized in a certain area so it's better  for you to just uh stay on this on this area   so yeah here yeah let's say that having somebody  that is really well trained uh is maybe not uh the   only thing it's also something that somebody  has experienced on the field that already has   um ability to read those literatures uh to go  through that those databases to search with those   keywords etc if you have ever done that before  to be honest do it once just once and you will   and from there you will ask each type an expert to  do that for you because i have done it myself and   at the end it's a nightmare to do this kind of  thing so i prefer to have it to do that exactly   and there is one more thing you know as you  already mentioned sometimes it has many aspects   yeah so maybe sometimes you you really require uh  input from a team rather than one single person   although one single person will put together a  report and you you may require and because field   is is very specific if it's very uh if you  require a very specialized skill set exactly   so then you might really require an opinion  from an and direct expert within the field   you know so but still i i think as you  already mentioned it really requires um   hard and soft skills uh and it's not only  reading and understanding it's as you know   it's also writing exactly scientific scientific  and technical writing now is also a part of it   and so we need to find uh people who really  has good background can read right understand   scientifically have sound backgrounds but also  can write well so um in in that in that transition   if i can say so how real quality can help then  manufacture so you have the ability i think with   your people to to help within the different fields  in the medical device uh in vitro diagnostic   so to do the right thing about that with  performance evaluation but to do all the   exercises that we talked about today yeah exactly  i mean like as you know as i have mentioned state   of the art is part of performance evaluation  planning it goes into scientific validity and   lately at the end it goes into your performance  evaluation report or clinical evaluation report   so and it requires literature searching it  requires as we have discussed all these details   so we as a re-quality we are working with  highly skilled uh medical writers and we have   medical writers having their phds in the field  of biochemistry immunology oncology neuroscience   cardiovascular diseases and so we definitely can  provide all these skill sets and now we have been   working in the field for quite some times in ivdr  and mdr now uh we are also building up this skill   set and you know we are developing as we we work  through with with notified bodies so we definitely   can help so yeah so don't hesitate as you see  so uh hakan is really uh knowledgeable on this   field and he has the team to to do that so uh  don't hesitate to call hakkan inan so from real   quality for for that uh don't go don't go also  on the show notes you will have all the details   about uh your the linkedin page or the the uh the  webpage of real quality uh so i will also place on   the channel some some links for you for maybe a  better understanding of what is sota and uh what   is state of the art and if you have any questions  don't hesitate you can reach out to us on linkedin   reach out to us also uh through the the websites  and ask any of the of the questions that you have   and yeah as i said if you need really if you  have any projects where you need maybe a lot   of support related to that don't hesitate to go  and call hakan in and for that okay so it was   really a pleasure to have you today i hope you  yeah i hope the people will be really getting   some support by listening to us and listening  to what what we are talking about in terms of   state of the art uh yeah and i hope yeah then  at the end also that uh people that are needing   really help they can really contact contact you  and get support from you yeah okay exactly always   pleasure talking to you thanks for having me thank  you that we we really could help people out there   who are struggling with the current changes in  medical device and mutual diagnostic device uh   updates yeah don't don't don't forget ivdr is  coming soon also so 26th of may 2022 next year   but uh it will be quick so i don't hesitate to uh  to get some support for uh for all your clinical   evaluation report or your performance evaluation  or any document that you need where there is   a need of some technical writer okay so i can  thank you and i wish you a nice day thank you you

2021-07-06 23:12

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