Against the following criteria:

  • EU MDR
  • EU MDD
  • MDSAP including all participating members (Brazil, Canada, USA, Japan, and Australia), official observers (The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme, European Union) and affiliate members (Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) and Republic of Korea’s Ministry of Food and Drug Safety
  • ISO 9001:2015
  • ISO 13485:2016
  • ISO 14971:2019
  • Quality Agreements
  • Contract Agreements
  • Vendor Agreements
  • Quality Management System Process

Quality Management System
ISO Statutory
MDD (European Union)
USA FDA
ANVISA (brasil)
PMDA (Japan)
MDALL (Canada)
TGA (Australia)