The medical devices manufactured by our clients are know for their safety, reliability and quality for their users.
We aim to support this high standard with our professional expertise and the flexibility of our consulting services.
You are looking for advice or support in any of the following areas within medical devices?
- Fulfillment of the requirements of the new MDR
- Creation or review of your QMS
- Introduction of new processes (incl. training of employees)
- Realization/remediation of requirements stemming from (FDA) audits or their preparation
- Risk management
- Technical writing
- Products - projects - processes
- Quality- Review methods - audits
- Technical documentation / Technical writing
- Risk management according to ISO 14971 (medical devices)
- ISO 13485/FDA 21 CFR Part 820 compliance
- New apects of the MDR
- Internationalisation and localizing
Within the framework of larger or urgent projects, we can count on the support and knowledge of colleagues from our extensive network working in the same field, but also experienced in other areas.