It’s done – also this year Human Med completed three QM audits without any nonconformities (!):
- Surveillance audit EN ISO 13485 (QM system for medical device manufacturers)
- Surveillance audit according to Directive 93/42/EEC, Annex II (without Section 4)
- Recertification ISO 13485 according to MDSAP
All departments involved in the realization and marketing of our products were inspected – purchasing, development, production, incoming goods, warehousing, sales and shipping – even management was audited.
Why is this success so important for Human Med? Because it shows that we have a well-established and functioning QM system – that we work well as a team despite the high regulatory requirements and can offer doctors reliable systems with high investment protection and great safety for their patients.
Still – we will not lean back because after the audit is before the audit: The next one is expected to take place in spring 2023, then hopefully along with the certification according to Regulation (EU) 2017/745.
We will keep you up to date!