Medical Device Developers and/or Manufacturers (MD companies or their OEM)

• Development under local or global Quality Management System (QMS) according to Medical Device Regulation (MDD/MDR)
• Manufacturing under ISO 13485, ISO 9000/9001 or GMP
• Global Registration (CE, FDA and ROW )
• Start-Ups (1-10employee), SMEs (20-300e) as well as the big global players (with up to >100ke) 

In-Vitro Diagnostics Developers and/or Manufacturers (IVD companies or their OEM)

• Development under local or global Quality Management System (QMS) according to In-vitro-Diagnostic Device Regulation (IVD/IVDR)
• Manufacturing under ISO 13485
• Global Registration (CE, FDA and ROW)
• SMEs (20-300e) as well as the big global players (with up to >100ke)

Combination Product Developers and/or Manufacturers (mostly Pharmaceutical Companies)

• Development under Pharma Quality System (PQS) and Medical Product Directive (MPD)
• Manufacturing under ISO 13485 or GMP
• Registration with Marketing Authorization Application (MAA at EMA) or Biologics License Applications (BLA at FDA)
• Confirmation of General Safety and Performance Requirements (GSPR) by NB under MDR incl. the required NBOp
• the big global players (with up to >100k e)