March 1st, 2022
Mid-size Company (10-49 employees)
QMS Audit: 12 months
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: pending
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
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.