April 21, 2025 – Ryden is streamlining regulatory compliance for life sciences with the launch of a comprehensive compliance bundle that integrates five key regulatory frameworks. This bundled approach simplifies compliance management for medical device and Life Science manufacturers, ensuring seamless alignment with global standards.
What’s Included in the Compliance Bundle?
This unified solution covers:
ISO 13485:2016
ISO 14971:2019 & ISO 24971:2020
EU MDR 2017/745 QMS – European regulatory requirements for medical devices. (Note: Does not include a full ISO 13485 assessment.)
FDA Labeling & UDI (801 & 830) – Unique Device Identification (UDI) and labeling compliance.
FDA QMS Core (803, 806, Part 7 & 820) – Key FDA quality system regulations. (Note: 820 does not include a full ISO 13485 assessment.)
Simplifying Compliance with an Integrated Approach
Regulatory complexity continues to challenge life science companies, with overlapping requirements across different markets. Ryden’s bundled solution provides a harmonized compliance framework, reducing the burden of managing multiple regulations separately.
“Our goal is to simplify compliance by offering a structured, all-in-one approach. This bundle ensures manufacturers can meet critical global requirements while reducing redundancies and compliance risks,” said Adam Foreman, CEO at Ryden.
By combining these five regulatory frameworks, Ryden empowers life science organizations with a more efficient, cost-effective, and scalable approach to compliance.