Notified Body
Intertek Capacity
Audits in around 6 months
Last tried 12/2022
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 30th, 2022
Review by mid-size company (10-49 employees)
Wait times
QMS Audit: pending
QMS Certificate: pending
Techdoc Audit: 6 months
Techdoc Certificate: pending
Ratings
February 28th, 2022
Review by small company (<10 employees)
Wait times
QMS Audit: pending
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
Comment on Duration and Cost
They are very friendly, responsive and motivated to answer questions
Choosing a notified body is harder than choosing a hair dresser. You can change that.