Notified Body
SGS 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.
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.
November 8th, 2022
Review by small company (<10 employees)
Wait times
QMS Audit: pending
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
Comment on Why You Didn't Choose Them
Not accepting new clients.
March 30th, 2022
Review by small company (<10 employees)
Wait times
QMS Audit: 3 months
QMS Certificate: 1 months
Techdoc Audit: 3 months
Techdoc Certificate: 1 months
Ratings
Comment on Duration and Cost
1,5 years from QMS audit to CE marking of our product
Comment
after 1 year, we got comments about our intended use which was not accepted as a medical device. This was a horror after it costed us 1 year of hard work to hear that it is not even a medical device coz the intended use statement is not complete. No one wanted to help us out with our intended use and frustrating part of that it was just someone's opinion.
March 8th, 2022
Review by very large company (250 employees or more)
Wait times
QMS Audit: pending
QMS Certificate: pending
Techdoc Audit: 6 months
Techdoc Certificate: 6 months
Ratings
Audit Stage
ISO 9001. ISO 13485 (MDSAP) and CE (MDD) certification for 9 years in my previous company. Stopped and went to another NoBo this year
Comment on Duration and Cost
We had troubles with our techdoc review some years ago, could not agree with the reviewer who was very picky. He gave no warning that we were exceeding the max review time of 6 months and our CE was suspended, so we could not CE label our products anymore (and sell). Image what this meant for us. Any NC they bring up, takes extra time from them. They obviously bill that. Having many NC's is also very costly.
Comment
Communication was sometimes very difficult. Never clear answers. Two years ago they said they would be MDR designated soon. Last year the same. I think they were only designated recently.
Choosing a notified body is harder than choosing a hair dresser. You can change that.