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Notified Body

SGS (Finland)

CE 0598

Reviews of SGS, a Notified Body in Finland

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 1st, 2022

Mid-size Company (10-49 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: 12 months

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

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

Cost

50.000€

Comment on Duration and Cost

We haven't received proper requirements for the audit in advance and this has delayed the audit by 1-2 months

Comment

We have been in the process to certify our products for over 4 years. Still, just before the audit, the Notified body has questioned our device class (I,IIa, IIb or III) and even if we should be regulated under IVDR or MDR. This has caused a lot of unnecessary work, confusion, worry, delays and costs. And we are still not sure, what's the ultimate verdict by the Notified body. We have tried to clarify this issue many times with the national authorities and consultant companies, but nobody is willing to take the responsibility for the decision.

Our lead auditor has little to no experience in software development and only basic understanding of medicine. This has led to many meetings where we are explaining basic things related to both of these fields to her, even though WE are paying the Notfied body an hourly rate of close to 400 euros for these "consultations". This is nuts!

The notfied body is mandating certain certificates or trainings, e.g. for 62430, to be completed before an audit can be passed, but they are also the only company in the country, who are providing these certificates or trainings. So, basically they are forcing us to buy their products (which are not cheap). This should be against the competition legislation.

February 28th, 2022

Mid-size Company (10-49 employees)

qms audit done techdoc audit done

Wait times

QMS Audit: 5 months

QMS Certificate: 1 months

Techdoc Audit: 1 months

Techdoc Certificate: 1 months

Ratings

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

Cost

About 20.000€

Comment

With, the SGS everything has been very fluent so far.

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