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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 26th, 2022
Mid-size Company (10-49 employees)
Wait times
QMS Audit: 3 months
QMS Certificate: 2 months
Techdoc Audit: 1 months
Techdoc Certificate: 2 months
Ratings
Comment on Duration and Cost
MDD class IIa
May 25th, 2022
Mid-size Company (10-49 employees)
Wait times
QMS Audit: 4 months
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: 5 months
Ratings
Cost
20.000€
Comment on Duration and Cost
costs are artificially raised by strange and noncompliances extra reviews
Comment
during last audit a major noncompliance was raised but they only would see their answer and didn't response on any counterarguments (inclusing paragaphs out their own manual) leading to unnescessary delay and unreleated extra review times
February 28th, 2022
Mid-size Company (10-49 employees)
Wait times
QMS Audit: 7 months
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
Comment
I’ve worked with Dekra in a previous job as well. Sometimes it felt as if we were paying them for consultation rather than an audit. I certainly did not feel like I needed to hide things from them.
February 28th, 2022
Large Company (50-249 employees)
Wait times
QMS Audit: 6 months
QMS Certificate: pending
Techdoc Audit: 8 months
Techdoc Certificate: 2 months
Ratings
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