MDR - Transition

The previous regulations - the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC)...

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IVDR - Transition

The previous regulation - the EU Directive 98/79/EC - on in vitro diagnostics has been replaced by the EU Regulation 2017/746 (IVDR) adopted by the European Council on 7 May 2017.

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Certification / Accreditation

  • DIN EN ISO 9001:2015
  • DIN EN ISO 13485:2016
  • ISO/IEC 27001
  • DIN EN ISO 17025

Further standards

for which, we would be happy to advise you:
  • DIN EN ISO 14971 Application of risk management to medical devices
  • DIN EN 60601 series: Medical electrical equipment (60601-01 - Part 1: General requirements for basic safety and essential performance, 606061-1-xx, 60601-2-xx, 60601-3-xx, ...)
  • IEC 62366 Application of usability engineering to medical devices (DIN EN 62366 Usability)
  • IEC 62304 Medical device software - Software life cycle processes (DIN EN 62304 Medical device software - Software life cycle processes)
  • DIN EN ISO 14644-01 and -02 Cleanrooms and associated controlled environments
  • DIN EN ISO 11607 series: Packaging for terminally sterilized medical devices (11607-01 packaging, 11607-02 validation)
  • ZLG Validierung von Prozessen der Produktion und der Dienstleistungserbringung
  • EN ISO 14155-1 and -2 Clinical investigation of medical devices for human subjects


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FDA

Food and Drug Administration USA
  • 21 CFR Part 820
  • 21 CFR Part 11
  • 510K Einreichung
  • CGMP / Quality System (QS) Regulation Medical Device Good Manufacturing Practices

Guidelines

for which we stand by your side:
  • MEDDEV 2.7/1 rev 4.0 - Clinical evaluation of medical devices
  • ICH Guidelines, in particular GCP (Goof Clinical Practice)
  • Good Manufacturing Practice (GMP)
  • Good documentation practice (GDP)
  • Good laboratory practice (GLP)

EU Directives /Guidelines /Regulations

for which we can assist you
  • Machinery Directive 2006/42/EC
  • Regulation 536/2014 on clinical trials on medicinal products for human use
  • Regulation MDR 2017/745
  • Regulation IVDR 2017/746
  • Directive 90/385/EEC active implantable medical devices
  • 93/42/EEC Medical Device Directive