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White Papers

  • Quality Management System in Medical Devices
    Quality Management System in Medical Devices
    Read More
  • China Medical Device Industry
    China Medical Device Industry
    Read More
  • Regulatory Framework for Personalized, Custom-Made Medical Devices in Australia
    Regulatory Framework for Personalized, Custom-Made Medical Devices in Australia
    Read More
  • UDI Compliance : A Roadmap
    UDI Compliance : A Roadmap
    Read More
  • Regulatory Approach on Classification of Software as Medical Devices
    Regulatory Approach on Classification of Software as Medical Devices
    Read More
  • Blood Glucose Monitoring Systems (BGMSs) & Regulatory Aspects
    Blood Glucose Monitoring Systems (BGMSs) & Regulatory Aspects
    Read More
  • Understanding Medical Device Regulations in Brazil
    Understanding Medical Device Regulations in Brazil
    Read More
  • Regulation of Medical Devices and IVDs in India-Understanding CDSCO Requirements
    Regulation of Medical Devices and IVDs in India-Understanding CDSCO Requirements
    Read More
  • Role of Usability/Human Factor Engineering In the Management of Use-Related Risk
    Role of Usability/Human Factor Engineering In the Management of Use-Related Risk
    Read More

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What our Clients say

Director, Regulatory Affairs,

US based leading precision medicine company

We have had a good impression of Freyr and feel more than comfortable telling our partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.

Director, Regulatory Affairs,

US based leading precision medicine company

Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. I thought the support was very good and met with expectations. In addition, found the price reasonable given the workload.

Regulatory Affairs Officer

A Global Industry Leader in Medical Device Design and Manufacturing

You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!

Associate, Regulatory Affairs Team II,

Clinical & Regulatory Affairs Center,
A Korean Chemical Company

Thank you so much Freyr team for your support on the way in registering 3 of our medical devices in Philippines.
I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.

Manager, Regulatory Affairs

A Spanish Medical Devices Manufacturer

Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. That’s what is really important and gratifying. Thank you again and keep up the excellent work!

Director, Regulatory Affairs

US based top Sterilization company

The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?

   

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