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A One-stop Solution to All your
Medical Device Regulatory Requirements


Medical Device Regulatory Services

The Regulatory world is constantly changing, and to keep pace with the same compliantly, opting for medical device Regulatory consulting stands as a key for device and IVD companies. For over a decade, Freyr has been instrumental in keeping its customers aware of the updated regulations by providing compliant end-to-end Medical Device Regulatory Services. As a medical device Regulatory consulting services organization, Freyr ensures to bring safe, high-quality, and compliant medical devices and IVDs into the global markets faster. Our team of Regulatory experts will navigate the Regulatory complexities with ease and ensure all the medical device Regulatory requirements are addressed in a timely manner.

Medical Device Regulatory Services – A Comprehensive Portfolio

Freyr, as a proven Regulatory partner, provides end-to-end Medical Device Regulatory services that span across decoding medical device classification, compiling device documentation, medical writing, device registration, and acting as an in-country representative. We customize the process with respect to service and software assistance for end-to-end device approvals. With Freyr offices located across the continents, Freyr offers Regulatory services for market entry and Regulatory compliance across all regions.

  • Device Registration
  • Clinical Evaluation Report
  • Regulatory Strategy and Approach
  • Global Regulatory Intelligence
  • Staff Augmentation
  • Translation Support
  • Medical Device Labeling and Review
  • Design History File (DHF)
  • Device Technical File Publishing

Starting from medical device notification to medical device licensing, we adhere to a standardized medical device Regulatory strategy which builds a compliant pathway for quick medical device market access.

Freyr Expertise and Advantages

Medical Device Regulatory
Compliance & Insights

Be it an In Vitro Diagnostic (IVD) consulting or medical device consulting services, Freyr’s goal is to provide a heads up to its customers on the Health Authorities’ mandates and medical device/IVD regulations, maintain compliance, and ensure a quick and safe product launch in the global markets.

We ensure furnishing accurate information on medical device Regulatory requirements. Aligning with our medical device Regulatory consulting services, we periodically publish insightful material that takes you through medical device Regulatory compliance.

  • Blogs

    Top 5 Obstacles Encountered by Manufacturers in Medical Writing

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  • Case studies

    Regulatory Services for Medical Device Registration and LR Support in Thailand

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  • mandates

    CDSCO, India Has Included 8 New Device Types to The List of Regulated  Medical Devices.

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Need more clarity on your medical device Regulatory requirements? Book a meeting with our Industry experts!