QM-Consulting / Certification
Our experienced team acts as consultants for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements.
For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services:

- Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR
- Creating QM-Systems with procedural instructions and work instructions
- Technical Documentation
- Clinical evaluation
- Risk Manangement / Risk Analysis
- Essential Safety and Persormance Requirements
- Validation of processes
- UDI-labeling
- Consulting for Regulatory Affairs
- Internal audits and external supplier audits
- Accompaniment and support with inspections by authorities and Audits by notified bodies
- Communication with authorities