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.