Risk - Management,Analysis in Medical Technology

In the field of medical technology, systematic and proactive risk management, aligned with the internationally recognized standard ISO 14971, is more than just a mandatory regulatory requirement. While essential under the EU-MDR/IVDR and other global regulations, it’s truly the cornerstone of patient safety and a prerequisite for successful market access and sustained product presence. It’s all about early identification of potential hazards posed by your medical device, evaluating the associated risks, and minimizing them to an acceptable level—throughout the entire product lifecycle.

My extensive experience has profoundly illuminated the critical importance of a living and well-documented risk management process. I offer you practical, proven support to establish or optimize a robust yet efficient risk management process for your products.

Why Is This Crucial?

Because risk management is your superhero!

Guardian Angel Mode

Clearly, the top priority is to protect patients, users, and third parties from harm. Better safe than sorry, and safest is best.

Regulatory Whisperer

Achieve checkbox happiness with MDR/IVDR, FDA, and similar authorities. This ensures that market authorization isn’t a nail-biting experience but a straightforward process. Integrate your Risk Management with your Requirement and Project Management (e.g. with Polarion) and you get full traceability without additional effort!

Cost Airbag & Image Polish

Catch risks early, before they blow up your budget and tarnish your good reputation. Corrections after design transfer are very expensive, and a damaged image is even more so.

Design-Booster

Integrating risk thinking from the start leads to products and processes that are not only safer but often smarter and more user-friendly. It’s a win-win!

Trust Magnet

A product that demonstrably radiates safety magically attracts customers, partners, and investors. Trust is the best currency.

FMEA

In risk management, risk analysis is a vital tool. Among these, the FMEA (Failure Mode and Effects Analysis) is one I’m particularly passionate about. I’ve developed a freely accessible tool that aims to greatly simplify, and indeed enable (again), the Failure Mode and Effects Analysis.

Learn more about it on GitHub: pyFMEA

You can find more on the topic of risk management and risk analysis on a dedicated website. This site is still under construction, but it will offer training, pre-prepared risk analyses for various processes, process descriptions, and exemplary validations in the form of blogs and courses.

Learn more at: HApi

Do you need help with risk-related topics?

I’d be happy to assist!

Let's work together!