One (1) more acrediation was added to Freyr apart from ISO 9001:2015 and ISO 27001:2022.

Hyderabad, Germany - February 5, 2025  — Freyr Solutions, a leading global Regulatory solutions and services company for medical devices, is proud to announce its ISO 13485:2016 certification from the British Standards Institution (BSI Group). This certification marks a significant milestone in Freyr's commitment to maintaining the highest standards of quality services offered to the medical device industry.

The ISO 13485:2016 certification is a rigorous international standard that outlines the requirements for a comprehensive quality management system specific to the medical device industry. ISO 9001:2015 & ISO 27001:2022 certification further complement this framework. 

Achieving the ISO 13485:2016 certification validates Freyr’s service provision for global consultancy services in

  • Product Registrations
  • Regulatory Affairs
  • Clinical And Medical Writing
  • Quality Management Systems
  • Labeling
  • Artwork Services
  • Authorized Representation Services, Such As EAR, Swiss Rep and UKRP

to the Medical Device and IVD industry.

Clients and partners can continue to rely on Freyr's expert solutions, knowing they are backed by the highest standards recognized internationally in the medical device sector.

About Freyr Solutions

Freyr Solutions is a leading global regulatory solutions and services company that supports life sciences organizations in navigating the complexities of Regulatory compliance. Focusing on quality, innovation, and international reach, Freyr Solutions provides comprehensive solutions that enable companies to bring products to market while meeting Regulatory standards. The company's commitment to corporate social responsibility reflects its mission to foster positive change within the industry and the communities it serves.

  • 14+ years in the life sciences Regulatory landscape.
  • 1650+ global customers and growing.
  • 2300+ in-house Regulatory experts.
  • Global presence across 25+ countries.
  • 850+ in-country Regulatory affiliates across 120+ countries.
  • ISO 9001:2015 & ISO 27001:2022 Certified and Now certified for ISO 13485:2016.