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. 

At Key2Compliance, we believe that risk management is of utmost importance for every medical device and IVD company. It is crucial to have a comprehensive understanding of risk management and to continuously work with it throughout the entire product life cycle. 

To support you with this work, we are dedicated to providing you with the best tools available.

Our offering includes a basic training that can accommodate up to 10 individuals, and upon completion, you will receive a certificate. Additionally, we will provide you with Risk Management procedures and templates that can serve as valuable resources. Furthermore, you will have the opportunity to meet with one of our experienced consultants for up to 6 hours. During this consultation, you can discuss your specific device and gain insights on how to effectively manage its risks. 

Package content


Risk management training, pre-recorded module (1 hour) with certificate. Available for four weeks.


Risk management SOP with templates.


3 Workshops, 2 hours each.


By taking advantage of our comprehensive package, you can equip yourself with the necessary knowledge and tools to navigate the intricacies of risk management in the medical device industry.

We are committed to supporting your success and ensuring the safety and efficacy of your products.

Want to know more about this offer?

Get in touch with our specialists to see what your company can benefit from this course package.

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