Our guide simplifies GSPR compliance, helping medical device companies meet EU safety standards, streamline CE marking, and get market-ready faster.
About this Guide
Achieving GSPR compliance for medical devices in the EU requires careful planning, close attention to regulatory standards, and a proactive compliance strategy. Navigating the stringent safety and performance requirements of MDR and IVDR means manufacturers need to stay ahead with thorough documentation and effective conformity processes.
This guide provides clear, actionable steps to help medical device companies assess GSPR relevance, implement the right standards, and ensure full compliance. Gain the knowledge needed to streamline your path to CE marking and confidently bring your devices to market.
Download the guide now for expert insights on simplifying compliance.
View our other resources and company news
Guide Medical Device Software Testing for MDR/IVDR Compliance | Rephine Guide
Case Study Implementing a Site-Wide CPV Strategy to Strengthen Process Control
Blog Continued Process Verification (CPV) in GMP Manufacturing
Medical Device The Artificial Intelligence Act (EU 2024/1689) Whitepaper: Key Obligations, Risks, and Compliance
Guide When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide
Case Study Navigating DMF Registration in China with Rephine
Blog Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF
CSV Understanding ICH E6 (R3): Good Clinical Practice and Computerised Systems Validation
Guide