+++ Certification of Health Software +++

MDC Engineers and Manager Regulatory Affairs provide medical-technical and regulatory knowledge.
We consult, design and manufacture medical devices, in-vitro-diagnostic and laboratory equipment, which reflect the state-of-the-art and fulfill market-specific regulatory requirements.

Call us for a first design analysis and to discuss one of the following topics.

EU Pfeil

Registration of Medical Devices

  • Registration Processes in EU and USA
  • Representation in EU
  • Market Vigilance
EU Pfeil

of Medical Devices 93/42/EWG and In-Vitro-Diagnostics 98/79/EWG

  • Classification
  • STED (Standard Technical Documentation), 21 CFR 820.30 Design Control
  • Risk Analysis EN ISO 14971
  • Electromagnetic Compatibility and Electrical Safety EN ISO 60601 for Medical Devices and EN 61010 for In-Vitro-Diagnostics
  • Software EN ISO 62304 and 82304
  • Biocompatility EN ISO 10993
  • Usability EN ISO 62366
  • Implementation of Quality Management System EN ISO 13485
EU Pfeil

Design and Technical Services

  • Performance Test and Documentation
  • Contract Manufacturing ( ISO 13485 certified )
  • Maintenance and Repair

Website Operator: GWK Präzisionstechnik GmbH (GWK Precision Technology)
Gollierstr. 70, 80339 München, Germany
Tel.: +49-89-72 64 960-0, info(at)
Registrar: HRB 95950 | VAT: DE 129365607 | CEO: Christian Heese