Skip to content

+358 20 7446 800 

  • English
  • Suomi

Search

Show search form

Medfiles
  • Company
    • About us
    • History
    • Medfiles’ team leaders
    • Management team
  • Our Services
        • Human Medicines
          • Regulatory Affairs
            • CMC
            • New Marketing Authorisations
            • Marketing Authorisation Maintenance
            • Local Regulatory Affairs
          • Pharmacovigilance
            • PV System Set Up
            • Post-Authorisation
            • ICSR
            • QPPV
            • Medical Information
          • Clinical Trials
            • Clinical Trial Safety
        • Veterinary Medicines
          • Marketing Authorisation & PV Readiness
          • Regulatory Affairs
            • CMC
            • New Marketing Authorisations
            • Marketing Authorisation Maintenance
            • Local Regulatory Affairs
          • Pharmacovigilance
            • PV System Set Up
            • Post-Authorisation
            • Adverse Event Prosessing
            • QPPV
        • Medical Device & IVDS
          • Quality & Regulatory
            • QMS
            • Technical Documentation
            • Clinical and Performance Evaluations
            • Registrations
            • Post-Market Services
            • Labelling, Translations & Marketing Materials
          • Clinical Investigations and Performance Studies
          • Post-Authorisation & Clinical Vigilance
        • Drug-device combinations
          • Strategy and classification
          • Development, documentation and regulatory alignment
          • Clinical trials and investigations
          • CMC
          • Approvals and conformity
          • Safety & PMS
          • Lifecycle management
        • Food
          • Novel Foods
          • GRAS, NDI and FAP
          • Health Claims
          • Food and Food Supplement Labelling and Marketing Materials
          • FSGs and FSMPs
          • Regulatory Positioning and Strategies
          • Clinical Studies
        • Feed
          • Regulatory Positioning and Strategies
          • Feed Material and Additive Registrations
          • GRAS and FAP
          • Labelling and Marketing Materials
          • Feed for Particular Nutritional Purposes
  • Insights
  • Careers
  • Contact us
    • Contact form
    • Contact our units
    • Offices
    • Invoicing

Product: Medical devices and IVDs

  • Regulatory work with medical devices and IVDs for over 20 years

    17.02.2026

    Eric Medfiles
  • Q&A: EU MDR and IVDR notified body processes and transition periods explained

    07.01.2026

  • When does your medical device need a clinical investigation?

    14.11.2025

    clinical investigation
  • Free webinar: Medical device clinical evaluation – how to document it under the MDR and how to prepare for a clinical investigation? 

    14.08.2025

    Webinar on clinical evaluation
  • Promotional material compliance in the Baltics: Key requirements for medicines, medical devices, food supplements and cosmetics

    06.06.2025

    Promotional material compliance in the Baltics
  • What importers and distributors need to know about EU MD and IVD regulations – regulatory compliance, labelling and marketing materials

    24.03.2025

  • EU IVDR: Ensure compliance with technical documentation, notified body processes and transition periods

    27.01.2025

    EU IVDR
  • What to know about medical device and IVD class changes and transition periods?

    01.08.2024

  • A team of 14 experts ensures high-quality regulatory and pharmacovigilance services in the Baltic countries

    18.03.2024

    A TEAM OF 12 EXPERTS ENSURES HIGH-QUALITY REGULATORY AND PHARMACOVIGILANCE SERVICES IN THE BALTIC COUNTRIES
Previous 1 2 3 Next
Medfiles - Securing a healthier tomorrow

© 2026 Copyright Medfiles.
All rights reserved.

Privacy Policy
Notification Channel

WDB Group

Services

Human medicine
Veterinary medicine
Medical Device & IVD
Drug-device combinations
Food
Feed

Contact

Rajatorpantie 41 C, FI-01640 Vantaa, Finland
VAT: FI10475691

+358 20 7446 800

Contact form
Subscribe to our Newsletter

© 2026 Medfiles • Built with GeneratePress