Risk management for Medical Devices and IVDs
Making Medical Devices Safer…together!
At GBA Key2Compliance, we believe that risk management is not just a regulatory requirement – it’s a cornerstone of patient safety and product success.
With the harmonization of ISO 14971:2019/A11:2021 with the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746, risk management has taken on even greater significance.
This alignment ensures that manufacturers are not only meeting compliance requirements but are also actively contributing to safer, more effective medical technologies.
A continuous process
Risk management is a continuous process that spans the entire product life cycle – from design and development to post-market surveillance.
A robust risk management system helps you:
- Identify and mitigate potential hazards early
- Ensure compliance with EU regulations
- Enhance product quality and reliability
- Protect patients and users
- Build trust with regulators and stakeholders
We can support you in navigating the requirements, providing personalized guidance on risk analysis, risk evaluation, risk control, and documentation all to implement an effective risk management process with expert consultation and training.
Risk Management Introduction Package
- to get you started
ISO 14971:2019/A11:2021 has been harmonized with the EU Medical Device Regulation (MDR) 2017/745 and the EU In Vitro Medical Device Regulation (IVDR) 2017/746.
This harmonization is important and has implications for your organization and device. How to facilitate compliance with EU regulations and to enhance patient safety.