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Notified Body
These are user-submitted reviews of medical device companies describing their experience working with this notified body. This includes how well-organized the notified body was, technical proficiency of the auditor, wait times and cost.
Important Notes
Notified bodies typically work with many different auditors, some of which are freelancers. That's one of many reasons which may lead to strongly varying reviews of the same notified body.
And lastly: Even though some reviews may be negative, the goal is not to rant about notified bodies. We've built this to facilitate the sharing of information between Healthcare companies. The goal is to improve Healthcare by helping everyone bring medical devices to market in a safe, predictable, affordable and fair way.
As manufacturers get to choose their notified body, these reviews should help companies choose one which is fair, well-organized and technically competent.
May 25th, 2022
Small Company (<10 employees)
Wait times
QMS Audit: 0 months
QMS Certificate: 1 months
Techdoc Audit: 1 months
Techdoc Certificate: 1 months
Ratings
Cost
25.000€ incl ncrs
Comment
I have no reference for medical regulatory pragmatic rating. Compared to space 9100 i would say this is not at all pragmatic
May 19th, 2022
Mid-size Company (10-49 employees)
Wait times
QMS Audit: 4 months
QMS Certificate: 1.5 months
Techdoc Audit: 1.5 months
Techdoc Certificate: 0.5 months
Ratings
Cost
Application review (3000 euro); Year 1 audits (20000 euro); Surveillance audits (5000 euro); unannounced audits (7000 euro)
Comment on Duration and Cost
Timelines and costs very clear up front.
Comment
Good communication, can call them with questions. Freelance auditor was good and had sufficient knowledge. Back and forth about significant/non-significant changes to certified product was good experience. They were quick to review and accept product changes.
March 30th, 2022
Small Company (<10 employees)
Wait times
QMS Audit: 2 months
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
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