Quality Management

ISO 13485 certification in 7 steps – Our experience report

The introduction of a quality management system in accordance with ISO 13485 is often a challenge for manufacturers of medical devices. We have been able to support our customers from the initial idea to successful initial certification in numerous projects – and this has resulted in a clear plan with 7 steps. Here is our experience report for you.

Our experience shows:

First, we assist in selecting the notified body, as this is a crucial decision.
Then we work with you to develop a tailor-made QM system, including a QM manual.
The processes described are implemented with the teams – training included.
We put everything through its paces in an internal test audit.
This is followed by the official certification audit – and with our support, our customers pass with flying colours.
We also provide support during the surveillance audits in the following years.
Finally, we prepare you specifically for recertification in the fourth year.

Our conclusion:

With the right ISO 13485 consulting, manufacturers save time, avoid typical pitfalls and achieve certification faster.

Are you facing initial certification according to ISO 13485? Contact Dilek Imre (info@sinovo.de) – we will be happy to support you!