Management Systems

Unrivalled experience supporting you (re-) design, document, implement & maintain your EN ISO 13485:2016 Quality Management System to:

  • address, integrate and meet EC MDR & IVDR, CFR820 transition to ISO 13485, MDSAP and other national regulations / requirements / standards
  • ensure efficiencies in management, processes, personnel, materials / supply chain, operations and distribution to suit your business, services and products
  • reduce business and user / patient risk
  • provide the necessary data to enable market surveillance & vigilance
  • continually appraise and improve performance
  • maintain your systems certifications and clearances to market.

Incorporating & embracing specific country requirements such as:

  • The Medical Device Single Audit Program (MDSAP)

  • Japan MHLW Ordinance No. 169, (QMS Ordinance)

  • USA FDA CFR820 transition to ISO 13485

  • Brazilian Good Manufacturing (BGMP) Certification

  • China Good Manufacturing Practice for Medical Devices

  • Mexico GMP Requirements & Technovigilance

Improving people, products/services, user experience, processes & systems for business advantage. Supporting you drive, maintain & develop your QMS (see In-House Expertise) and deliver Training in Quality Systems including EN ISO 13485:2016, MDSAP and other National GMP Requirements.

C Li C for Support