Hey ho!
As new EU MDR will be truly important soon (May! Five month left!), I want to update our internal audit compliance matrix. You know, that is this Excel file with all chapters of ISO 13485:2016 in one column, and all MDD, Canada MDR SOR 98/282, QSR and else requirements in the following columns. Now, I have to add the MDR requirements. And I was wondering, if someone has already compiled a list comparing the different requirements, including MDSAP, South Korea GMP (has been updated recently)?
I assume, that no such list exists yet. So, I wonder if here are people who would like to create such a list, together with me? I think, for regulatory requirements, maybe we could create a sub group here, where we share all this knowledge? All the consulting companies take a lot of money for their service, and my boss does not want to pay more people for the regulatory department, but always wants new markets! China, Taiwan, Saudi Arabia, Brazil, South Africa, to name a few. It is already a pain in the ass to not make mistakes during adverse event reporting (which country Z CA do I also have to inform if in country X something happens with product Z??).
I mean, we all share the same spirit! But the days are short, and there is always somethink important to do. ASQ and RASP are not a help, either. Is there another organization, preferable adhering to the open source community ideals, who is doing this kind of work? Or, if not, should we found one? Actually, I think we should kick asses of our competent authorities to get a single regulation world wide. Currently, we are only feeding bureaucrats, but the patients need our products! So, all of our CAs should get a major nonconformity for not being customer oriented!
Just my two cents!
Please share your thoughts!
Wolf
As new EU MDR will be truly important soon (May! Five month left!), I want to update our internal audit compliance matrix. You know, that is this Excel file with all chapters of ISO 13485:2016 in one column, and all MDD, Canada MDR SOR 98/282, QSR and else requirements in the following columns. Now, I have to add the MDR requirements. And I was wondering, if someone has already compiled a list comparing the different requirements, including MDSAP, South Korea GMP (has been updated recently)?
I assume, that no such list exists yet. So, I wonder if here are people who would like to create such a list, together with me? I think, for regulatory requirements, maybe we could create a sub group here, where we share all this knowledge? All the consulting companies take a lot of money for their service, and my boss does not want to pay more people for the regulatory department, but always wants new markets! China, Taiwan, Saudi Arabia, Brazil, South Africa, to name a few. It is already a pain in the ass to not make mistakes during adverse event reporting (which country Z CA do I also have to inform if in country X something happens with product Z??).
I mean, we all share the same spirit! But the days are short, and there is always somethink important to do. ASQ and RASP are not a help, either. Is there another organization, preferable adhering to the open source community ideals, who is doing this kind of work? Or, if not, should we found one? Actually, I think we should kick asses of our competent authorities to get a single regulation world wide. Currently, we are only feeding bureaucrats, but the patients need our products! So, all of our CAs should get a major nonconformity for not being customer oriented!
Just my two cents!
Please share your thoughts!