Notified Body
IMQ Capacity
Unknown
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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.
March 9th, 2022
Review by small company (<10 employees)
Wait times
QMS Audit: 3 months
QMS Certificate: 1 months
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
March 1st, 2022
Review by small company (<10 employees)
Wait times
QMS Audit: 18 months
QMS Certificate: 1 months
Techdoc Audit: 18 months
Techdoc Certificate: 18 months
Ratings
Cost
More than 20.000€
Comment on Duration and Cost
Too long time to receive any response. Some NC without any sense
Comment
More than 6 months to checks their forms and start to review our TF
Choosing a notified body is harder than choosing a hair dresser. You can change that.