Qualitymanagement- and Regulatory Affairs Services

  • EU, USA, ROW (e.g. Canada, Australia)

  • Medical Devices according to MDD/MDR

  • Active Implantable Devices according to AIMDD/MDR

  • In Vitro Diagnostic Devices according to IVDD/IVDR

  • Combination Products according to MDR (article 117) and FDA 21 CFR Part 4 (CPGMP)

  • Quality Management according to ISO 13485 and FDA 21 CFR Part 820

  • Auditing (Mock Audits, MDSAP, QSIT)

  • Due Diligence (e.g. company take-overs, investments)

  • Regulatory Opinions / Regulatory Strategies

  • Good Manufacturing Practice (GMP)

  • Good Automated Manufacturing Practice (GAMP

  • Good Engineering Practice (GEP)

  • Good Documentation Practice (GDP)

  • Good Laboratory Practice (GLP)

Medical Devices

Medical Device Software

In-Vitro Diagnostic Devices

Combination Products