View all Notified Bodies

Notified Body

IMQ (Italy)

CE 0051

Reviews of IMQ, a Notified Body in Italy

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

Small Company (<10 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: 3 months

QMS Certificate: 1 months

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: yes

March 1st, 2022

Small Company (<10 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 18 months

QMS Certificate: 1 months

Techdoc Audit: 18 months

Techdoc Certificate: 18 months

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: no

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

Share your notified body experience to help other people.

Choosing a notified body is mired with intransparency. You can change that.

No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.