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Global Market Access

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Medical Electrical Equipment & Devices Global Market Access | Eurofins E&E

Gaining access to multiple markets for Medical Devices can be a difficult and time consuming process, especially when there is a lack of in-house knowledge of all the regulatory authorities involved.

Eurofins Medical Device Testing’s testing and certification services offer a number of routes to market for medical devices and medical electrical equipment, including:

  • CE Marking & Notified Bodies - Europe
  • NRTL listed Eurofins MET Mark certification - US & Canada
  • IECEE CB Scheme – access over 50 countries worldwide
  • Medical Devices Single Audit Program (MDSAP) – US, Australia, Brazil, Canada & Japan
  • Global Market Access - custom service for your chosen combination of the above and/or other regions and countries

Global Market Access – customised to your requirements

Eurofins Medical Device Testing’s Global Market Access service provides manufacturers with the assistance necessary to bring Medical Electrical equipment and devices to their chosen combination of markets.

This tailored, custom service helps identify technical requirements, and co-ordinate the certifications and transactions between manufacturers and the necessary in-country authorities. Drawing upon our expertise and experience, Eurofins Medical Device Testing can manage non-tariff trade barriers, licences, local certifications and national technical requirements for you.

FDA Approval

Gaining FDA approval for the US is vital to success in the active medical device market.  Eurofins Medical Device Testing & certification services offers expert services for pre-submission as well as formal submission of 510(k), De Novo and PMA devices. Whether your device is Class I, II or III, Eurofins MET labs can help you get through the FDA approval process.

Medical Devices Single Audit Program (MDSAP)

The MDSAP is an international cooperation of different regulatory authorities with the objective of the global harmonization of medical device regulatory requirements.

Eurofins Medical Device Testing and Certification services acts in cooperation with a MDSAP recognized auditing organization, DSQ Medizinproduct GmbH. As such, we are allowed to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of all the regulatory authorities participating in the program, including:

  • US
  • Australia
  • Brazil
  • Canada
  • Japan

The European Union (EU) and The World Health Organization (WHO) Prequalification of In-Vitro Diagnostics (IVDs) Programme are Official Observers of MDSAP program.

Choose Eurofins Medical Device Testing to help you:

      ✔  Gain access to your chosen combination of global regions and countries
      ✔  Co-ordinate transactions between manufacturers and authorities
      ✔  Profit from our expertise and long-standing experience
      ✔  Utilise the Medical Devices Single Audit Program (MDSAP)
      ✔  Gain FDA approval for your medical electrical equipment

These services are available through our global network of Eurofins Electrical and Electronics (E&E) laboratories.