Hello all,
I'm interested in getting myself more up to speed with the new EU MDR.
As many of you have done, I've carefully read it and made lots of highlights and notes
But I know from experience that nothing is better than getting to know a regulation through practice, and the more diverse the better.
Now, my impression is that most small- and micro-manufacturers (my natural habitat
) are in denial or maybe think that they have lots of time, while they perceive the move to MDR as resource-hungry (I must admit that this notion is not completely unfounded!...). So I don't (yet?) get a lot of requests for help in that regard. I think bigger businesses have already mobilized, but they either "go it alone" with their in-house staff or have pockets deep enough to bring in heavy artillery, i.e. hire a fancy, large regulatory consultancy firm that pretty much does everything for them.
With that background in mind I'd like to make an offer. I'm willing to engage with manufacturers, free of any charge, to look into an MDR gap analysis* or otherwise support them towards transitioning to MDR. The extent / duration of my involvement can be discussed, keeping in mind that the goal is mutual benefit. I'm looking to gain more MDR experience and insight for a diverse range of device types, manufacturing processes and setups, novelty and risk levels etc. There will be no strings attached (unless you choose to tie them).
*) In this context, by gap analysis I mean examining the manufacturer's current regulatory situation and determining - in detail - what they need to do, and how, to get into compliance with the MDR. A "gap analysis" simply comparing the MDD's (old) text with the MDR's is of less interest I think, and of less practical benefit in any given specific context (a crude correlation between the MDD and MDR clauses can be found in the MDR's Annex XVII).
Please feel very welcome to PM me for any clarification or interest.
Thanks,
Ronen.
I'm interested in getting myself more up to speed with the new EU MDR.
As many of you have done, I've carefully read it and made lots of highlights and notes
But I know from experience that nothing is better than getting to know a regulation through practice, and the more diverse the better.Now, my impression is that most small- and micro-manufacturers (my natural habitat
) are in denial or maybe think that they have lots of time, while they perceive the move to MDR as resource-hungry (I must admit that this notion is not completely unfounded!...). So I don't (yet?) get a lot of requests for help in that regard. I think bigger businesses have already mobilized, but they either "go it alone" with their in-house staff or have pockets deep enough to bring in heavy artillery, i.e. hire a fancy, large regulatory consultancy firm that pretty much does everything for them.With that background in mind I'd like to make an offer. I'm willing to engage with manufacturers, free of any charge, to look into an MDR gap analysis* or otherwise support them towards transitioning to MDR. The extent / duration of my involvement can be discussed, keeping in mind that the goal is mutual benefit. I'm looking to gain more MDR experience and insight for a diverse range of device types, manufacturing processes and setups, novelty and risk levels etc. There will be no strings attached (unless you choose to tie them).
*) In this context, by gap analysis I mean examining the manufacturer's current regulatory situation and determining - in detail - what they need to do, and how, to get into compliance with the MDR. A "gap analysis" simply comparing the MDD's (old) text with the MDR's is of less interest I think, and of less practical benefit in any given specific context (a crude correlation between the MDD and MDR clauses can be found in the MDR's Annex XVII).
Please feel very welcome to PM me for any clarification or interest.
Thanks,
Ronen.
