Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear community,

Can you recommend consultants that you have used for MDR (not being yourself).  That can gap your current technical file and write a new one?  That is if you have company that knows MDR but you need extra set of hands that will not need much support from you.  If you can recommend someone, why do you recommend them?  

This is quite a wide question. Please specify what part of the world you are based, what is the device about (just mention terms used in classification like 'implantable' or  'active') plus the risk class. Obvously, a consultant that acts as that 'extra set of hands' is ideal. But for writing a rock solid TD, you need to get quite intimate with the device and its clinical context. A good consultant will therefore be communicating a lot.

By the way, I am NOT, I repeat NOT, available for this work. 

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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 12-Jan-2024 04:30
From: Anonymous Member
Subject: MDR Consultant Recommendation

This message was posted by a user wishing to remain anonymous

Dear community,

Can you recommend consultants that you have used for MDR (not being yourself).  That can gap your current technical file and write a new one?  That is if you have company that knows MDR but you need extra set of hands that will not need much support from you.  If you can recommend someone, why do you recommend them?  

This message was posted by a user wishing to remain anonymous

This was maybe not articulated well, of course we plan on communicating and supporting the consultant.  I was trying to convey that we know MDR regulation in Europe and we do not only need knowledge but hands on help as well.    We are located in Europe. 

Original Message:
Sent: 13-Jan-2024 03:38
From: Ronald Boumans
Subject: MDR Consultant Recommendation

This is quite a wide question. Please specify what part of the world you are based, what is the device about (just mention terms used in classification like 'implantable' or  'active') plus the risk class. Obvously, a consultant that acts as that 'extra set of hands' is ideal. But for writing a rock solid TD, you need to get quite intimate with the device and its clinical context. A good consultant will therefore be communicating a lot.

By the way, I am NOT, I repeat NOT, available for this work. 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 12-Jan-2024 04:30
From: Anonymous Member
Subject: MDR Consultant Recommendation

This message was posted by a user wishing to remain anonymous

Dear community,

Can you recommend consultants that you have used for MDR (not being yourself).  That can gap your current technical file and write a new one?  That is if you have company that knows MDR but you need extra set of hands that will not need much support from you.  If you can recommend someone, why do you recommend them?  

While I want to be respectful of your instruction that we shall not speak on our own behalf, I'll also say that my EU MDR clients (medical device manufacturers) aren't on the RAPS Forum and aren't interested in joining, as they are not EU MDR or regulatory experts (thus the reason they hired my firm).  But I can arrange for you to speak with, or get a reference from, my clients.  Feel free to contact me offline if you are interested in that route.

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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 12-Jan-2024 04:30
From: Anonymous Member
Subject: MDR Consultant Recommendation

This message was posted by a user wishing to remain anonymous

Dear community,

Can you recommend consultants that you have used for MDR (not being yourself).  That can gap your current technical file and write a new one?  That is if you have company that knows MDR but you need extra set of hands that will not need much support from you.  If you can recommend someone, why do you recommend them?