• QMA transition to the new EU MDR and/or MDSAP
  • Implementation of ISO 13485:2016
  • Implementation of ISO 14971:2019 or ISO 14971:2012 or ISO 14971:2007
  • Gap Analysis
  • Design and Development of products from idea to market
  • Risk Management
  • Quality Management System Procedure(s) Generation
  • Pre-market Submissions and Licensing (PMA, 510k, Registration, etc.)
  • Technical File Generation and Maintenance
  • Design and Development of products from idea to market
  • Clinical Evaluations
  • Post Market Surveillance
  • Vigilance
  • Remediation Projects or Initiatives
  • 483 Response

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