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:

The next audit is never far away
The next audit is never far away
  • 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