How NAMSA’s Regulatory Team Can Help You

NAMSA, the world’s only Medical Research Organization (MRO), provides clients with various regulatory affairs, quality system and clinical research capabilities throughout APAC, Europe, the Middle East and the Americas. Our Associates average 10 years of regulatory experience, and many team members possess over 20 years’ experience; some have held various positions within global regulatory agencies and NBs.

NAMSA has a team specifically dedicated to the preparation of Clinical Evidence Reports (CERs), in addition to our Clinical Team that develops and executes pre- and post-market clinical studies to meet EU MDR and IVDR clinical data requirements.

Examples of NAMSA services, pertaining to the MDR/IVDR, include:

  • Prepare quality plans to ensure compliance before the end of the MDR/IVDR transition period
  • Conduct gap assessments:
    • CER procedures to MDR and current MEDDEV 2.7.1 and IVDR
    • Existing CERs to MDR and current MEDDEV 2.7.1
    • Technical File content and structure to MDR and IVDR
    • Review quality system and regulatory procedures against MDR and IVDR and ISO 13485
  • Assist in mitigation of identified gaps
  • Convert existing Technical Files and ER Matrices
  • Design and execute MDR-compliant clinical investigations and IVDR-compliant clinical performance studies
  • Assess device classification, per new rules, and prepare classification justification
  • Prepare compliant CERs for new and legacy products
  • Create or revise systems and SOPs to meet MSDR/IVDR requirements as well as ISO 13485:2016
  • MDR and IVDR training for:
    • Senior management
    • Regulatory and quality teams
    • Clinical staff
  • Assist in revising contracts with importers and distributors
  • Conduct mock audits
  • Conduct mock recalls to assess traceability

Additional Information

To learn more about NAMSA’s regulatory consulting, quality systems and clinical research services, please contact us at: namsa.com/contact-us or +1-866-666-9455 (toll free) | +1-419-666-9455 (outside of USA). You may also learn more by visiting the following links: