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Updated EU MDR regulatory matrix wanted

Wolf.K

Quite Involved in Discussions
#1
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
 
Elsmar Forum Sponsor
#2
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
Great idea and one I will raise my hand to help with!
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Sorry to be a party pooper, but IMO this is all messed up.
my boss does not want to pay more people for the regulatory department, but always wants new markets!
Sure - isn't that what we all want, to get something for nothing?... There is no difference between expecting consultants to work for free (have you ever considered that we also need to make a living? I don't drive a Jaguar) and overworking "the boss"'s own employees, to squeeze a few more drops out of the lemon, or even expecting them to "just deal with it" in their own time, off-clock (read: unpaid).
I mean, we all share the same spirit!
And what exactly is that spirit?... Putting up with being exploited, so that the corporate balance sheet could look a little nicer, because "the boss can"? What would you think of a business not budgeting for, say, computers, and then asking people to donate the missing computers, because suppliers "charge so much for them"? What's the difference between a computer and RA expertise? Aren't both necessary inputs?
preferable adhering to the open source community ideals
Sorry, but what exactly ARE these ideals?
As far as I know, the open source movement started as a revolt against Microsoft's (and maybe others) monopolism - Microsoft was keeping its source code secret in order to dominate the market and keep users at their mercy, so they could jack up prices. So people said, we're going to share our codes, so everyone can contribute voluntarily to create an alternative for Microsoft, i.e. open the market and enable fair competition. Indeed, I used Open Office's alternative to MS Word for several years. It wasn't bad, but it wasn't as good as Word I must admit. But that's not why I eventually returned to MS Word. I returned because my clients were complaining about document compatibility. My OO documents were getting messed up when my clients reopened them in MS Word (I never met a company that has moved away from Microsoft).
RA consultants are light years away from having a monopoly similar to the one Microsoft had, de-facto. We are competing in a free market, and believe me that over the 15 years I've been in this prices HAVE gone down.
So, is your goal to bring down "big bad consultants", making unfair profits?... I'm sure it's not. On the other hand, applying an unpaid DIY approach, with or without collaboration, to bail out incompetent/shameless bosses, is not where open source started.
we should kick asses of our competent authorities to get a single regulation world wide.
Good luck with that. If that's what you are after, you should get into politics. Are you unaware of how many years of ruthless political debates it took to bring about the MDR?... and that's just the EU, not the whole world, and it's not even working properly yet!...

***************************

To summarise: If you've done part of the work and want to share it here, calling others to voluntarily contribute towards completing the job, so that everyone can benefit from such a document, that's noble. But I would avoid the slogans and the grandeur unless changing the world is really your life mission (BTW, I never heard of anyone who fought to change the world who didn't make big personal sacrifices for that).
 

Wolf.K

Quite Involved in Discussions
#4
Hi Ronan,
I agree with you in most points. Well, maybe you should have a look on Linux/Android or ReactOS, but generally speaking, I was thinking about the spirit here in the forum: that people help each other.
In my QMS, I have to consider about 30 country regulations. We have two more people only working in Regulatory Affairs, but it is impossible to keep all regulations in mind. Therefore, e.g., if we have to report an adverse event, we always have to think "ok, it happend in country X, which other contry requires us to report there too".
I hope, that with MDR it will get much easier, at least within Europe. I also hope, that MDSAP will help much. Still, there are so many other countries. Currently, I have to dig into Korea KGMP, but my knowledge of the language there is nil, and should I trust Google Translate?
To summarize: currently I am updating my regulatory matrix from MDD to MDR, and hopefully within 2020 I will have the table to include: MDR, 13485, MDSAP, QSR, KGMP, Taiwan GMP and else. Then I will put it online!
 

Watchcat

Trusted Information Resource
#5
What would you think of a business not budgeting for, say, computers, and then asking people to donate the missing computers
This is done. Some (maybe all, I don't know) CROs hire temporary employees and require them to bring their own laptops. I haven't seen it in the device industry, but I haven't been a temporary onsite employee in the device industry. Wouldn't surprise me.

the spirit here in the forum: that people help each other.
More and more, I think that people helping each other in these forums just enables industry to stumble on with inadequate resources (in terms of both quantity and quality). I think in many cases, the "helping" leads to a bad end, but in the long run, and no one connects the dots. They are always called "discussion" forums, but they are mostly overrun with Q&A, not discussions. Where can I find? What is required? Anyone have a template? How do I?

Hey ho!

I think we should kick asses of our competent authorities to get a single regulation world wide.
Why? Because this would make it easier and cheaper for industry to flail along lamely? What a low bar.

Unless you are just a fan of a One World Order, rather than competition?
 
Last edited by a moderator:

Wolf.K

Quite Involved in Discussions
#6
More and more, I think that people helping each other in these forums just enables industry to stumble on with inadequate resources (in terms of both quantity and quality). I think in many cases, the "helping" leads to a bad end, but in the long run, and no one connects the dots. They are always called "discussion" forums, but they are mostly overrun with Q&A, not discussions. Where can I find? What is required? Anyone have a template? How do I?

Why? Because this would make it easier and cheaper for industry to flail along lamely? What a low bar.

Unless you are just a fan of a One World Order, rather than competition?
Well, I have to agree, that the forum indeed includes many of the Q&A like threads. And that is not a bad thing. That is life-long learning.

And I am glad, that we (here in Europe) have a single Medical Device Regulation. That we soon have a single EU adverse event reporting database. Currently, we employ more people in the QM and RA departments then in the RD department. Stupid waste of resources. Cannot see any important differences between all the regulatory requirements here and abroad, but all the bureaucrats need to be payed, right?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
I present to the board an update on regulatory and quality for our medical device. We are a lean and small crew but we do invest in consultants. I tell them we can pay now or we can pay later. I can't be an expert in everything (60601, 13485, FDA, EU, Brasil, Biocompatibility, sterilization, etc); and even if I were my expertise ages like milk and not wine in the regulatory world. If I haven't touched something in two years I have forgotten most of it and the regulations have changed. We can go the cheap route and try to comply but in the end, we will be paying for it.

Its important to tell your bosses there is a cost to being compliant. That is a barrier to entry into this market but it must be paid.
 
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Watchcat

Trusted Information Resource
#8
That is life-long learning.
I think it is more often a textbook example of giving a man a fish instead of teaching him how to.

Currently, we employ more people in the QM and RA departments then in the RD department.
This profile is typical of an established device manufacturing company that wants to manage quality as needed to meet market needs, and to have access to those markets. At these companies QM and RA resources are critical to the business. If there are also more people in the QM and RA departments than in manufacturing (including people at a contract manufacturing facility), then something is wrong here.

This is not the profile of a product development company. Many device manufacturing companies have small R&D departments, but, however much they might insist otherwise, this is an strong indicator management is not particularly interested in product development. They may be keenly interested in being able to tell shareholders that they are "innovative," however.

I am glad, that we (here in Europe) have a single Medical Device Regulation.
Why? What benefits do you think it offers, to manufacturers and to their customers, compared to each country having its own?

we soon have a single EU adverse event reporting database.
Ummm, I think you meant to say that hopefully we will soon get a second try at a single EU adverse event reporting database, and we hope this one works out better than the first one. Although given the first effort, and that the second effort has stumbled already, I think a lot of people have their optimism well in check.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
I present to the board an update on regulatory and quality for our medical device. We are a lean and small crew but we do invest in consultants. I tell them we can pay now or we can pay later. I can't be an expert in everything (60601, 13485, FDA, EU, Brasil, Biocompatibility, sterilization, etc); and even if I were my expertise ages like milk and not wine in the regulatory world. If I haven't touched something in two years I have forgotten most of it and the regulations have changed. We can go the cheap route and try to comply but in the end, we will be paying for it.

Its important to tell your bosses there is a cost to being compliant. That is a barrier to entry into this market but it must be paid.
Wow. That's a nice speech but I still see you asking questions here (that should/could normally go to the consultants you "invest in"), on quite a regular basis.

What all you guys don't realise is that slowly but surely you drive independent consultants out of the market and eventually you'll be left with only a handful of big expensive RA firms that won't even be interested in your SME business because they'll have plenty of work and income from your multinational competitors.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Ummm, I think you meant to say that hopefully we will soon get a second try at a single EU adverse event reporting database, and we hope this one works out better than the first one. Although given the first effort, and that the second effort has stumbled already, I think a lot of people have their optimism well in check.
As far as the general public is concerned, EUDAMED 1.0 worked/works well. Technologically, it mostly met it's upfront defined goals. It was never meant for the general public use. If it "failed", it was more a matter of general EU (cross-Member-State) policy/conduct.
 
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