While I can't speak to the structural heart aspect, I can add a few notes:
- As you're at a small med device company, you may be cost conscious. I've used Intertek before and their prices were reasonable. My last company liked using them because we also used their testing lab which is in Boxborough, MA (noticed you're in MA so I'm pointing that out).
- At one point I got a quote from TUV SUD. I've heard they're very thorough and they had up-to-date information available on new regulations, but their prices were too high for a small company.
- I use BSI now so you could try them.
Like others have said, many are not taking on new clients, so get quotes per Richard's advice and assess from there.
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Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
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Original Message:
Sent: 15-Mar-2021 06:59
From: Peter Reijntjes
Subject: Notified Body?
Hi Chris,
I would like to add to the simple but excellent comment of Richard to also assure that you select a notified body which is accredited for your type of product. Not all notified bodies can assess all product categories. NANDO for medical devices
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
Original Message:
Sent: 15-Mar-2021 05:57
From: Richard Vincins
Subject: Notified Body?
Hello Chris,
Some Notified Bodies are not taking on new clients, so 1) contact a Notified Body to get a quote, 2) get a Notified Body who will perform the audit/Tech Doc review, and 3) what is the price for your endeavour, and 4) make sure it aligns with your entry time onto the market.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 13-Mar-2021 11:43
From: Scott Bishop
Subject: Notified Body?
Chris,
I will say that it depends on several things - 1) where your product is development wise and whether you have fully commercialized products or only in development stages (IE full 13485 implemented) as well as your geographic commercial intentions (US, EU, Global).
BSI is a reasonable starting point - that, depending on managers / contacts - are helpful with smaller companies.
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Scott Bishop
Houston TX
United States
Original Message:
Sent: 12-Mar-2021 10:12
From: Chris Cain
Subject: Notified Body?
Any NB recommendations for a small medical device company in the structural heart space?
Thank you, Chris
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Chris Cain RAC
VP, Clinical & Regulatory Affairs
Newton MA
United States
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