Freyr provides end-to-end services starting from device classification to market approval which includes appointing legal representative and guiding you in getting the certification like QMS etc. Our consultants are located worldwide so regardless of where you are located, we can assist you with regulatory issues offer a path to approval across multiple jurisdictions. We customize the process with respect to technical, service oriented and software assistance for the approval of medical devices according to the company size and ensuring high quality output.

Medical Device Registration - Specific Geographic Markets

Freyr has gained market approval for hundreds of medical devices of varied market clusters like US FDA, EMEA, GCC and APAC.

US Region

Freyr guides you in registering the device based on the below required approval procedures for US FDA Region.

  • Premarket notification 510(k)
  • Premarket approval (PMA)
  • De novo petition
  • Establishment registration and device listing

Download US Approval Process

European Union

Freyr aids in making the approval process easier in European Union and is adept in tackling the multi lingual and complex regulations of different agencies.

  • CE Approval
  • ISO QMS Certification
  • Appointing Authorised Representative

Download European Approval Process

Canada

Freyr can accelerate the device approval by getting the licences to market in Canada .

  • Medical Device Establishment license (MDEL)
  • Medical Device license (MDL)


     

Download Canada Approval Process

Medical Device Registration: Emerging countries (APAC)

Device registration process in emerging countries like APAC is a bit complex, read more about the processes for below listed countries.

Australia China India Japan Korea Malaysia New Zealand Singapore

End-to-end Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions

Freyr supported an Indian mid-size medical device company for effective Regulatory strategy and in-time 510(k) Submissions with 100% quality for compliance Download

CLIENT TESTIMONIALS

 
  • Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!

    Senior Regulatory Associate, Worldwide Regulatory Strategy
    A leading research-based global Biopharmaceutical Company

  • On behalf of the entire team, I’d like to thank you for your hospitality. We understand that hosting us took time away from your day-to-day activities, and we just wanted to say thank you for everything you did to make this a very interactive, productive and successful visit for us. We would especially like to pass along our appreciation to the entire Freyr team for partnering in our mission to serve patients.

    - Director, Supplier Performance Management, Global Regulatory Affairs & Safety
    Forbes Global Top 10 Biopharma Company

  • Thanks so much for all the help and diligence. We are so impressed by the way things have been handled by Fryer and the level of competence.

    We have another very similar project coming up in the next few weeks where we need exactly the same level and type of service which we will be delighted to talk to you further.

    – Program Manager, Regulatory Affairs – Global $1Bn Pharma Company

  • Thanks for the great work you are doing, sharing the great principles that Freyr uses for its employees and your focus on sustainability.

    – Head of Procurement, Fortune 100, Global Top 10 Consumer Healthcare & Pharma Company