Notified Body
SIQ Capacity
Not replying to emails
Last tried 10/2022
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.
November 17th, 2022
Review by mid-size company (10-49 employees)
Wait times
QMS Audit: pending
QMS Certificate: 2 months
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
Audit Stage
No waiting time at all - we are working with them since many years.
March 1st, 2022
Review by mid-size company (10-49 employees)
Wait times
QMS Audit: 2 months
QMS Certificate: 2 months
Techdoc Audit: 24 months
Techdoc Certificate: pending
Ratings
Cost
30.000€
Comment on Duration and Cost
Never get close to SIQ, they lure companies to get their financial resources but do not follow on their commitments and leave companies uncertified.
Comment
SIQ is our horror story.
Choosing a notified body is harder than choosing a hair dresser. You can change that.
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.