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)