QM-Consulting / Certification

Our experienced team acts as consultants for small and medium-sized companies who are manufacturers of surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements.

For manufacturers and distributors 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
  • Creating QM-Manual with procedural instructions and
    work instructions

  • Implementation DIN EN ISO 13485 and Medical Device
    Regulation 2017/745 MDR (until May 2021 also MDD 93/42/EEC)

  • Technical Documentation

  • Risk Management / FMEA Risk Analysis

  • Clinical evaluation according the latest MEDDEV 2.7/1

  • Essential requirements of Directive 93/42/EEC

  • Internal audits and external supplier audits

  • Accompaniment and support with inspections by authorities

  • Validation of processes

  • Consulting for Regulatory Affairs

  • UDI-labeling and 21 CFR 820 QSR

  • DIMDI-notifications