Application of Risk Management to Medical Devices according to EN ISO 14971
Risk Management is a key requirement during the entire life cycle of Medical Devices. It starts with development, continuing through a market introduction, continuous production, and Post-Market monitoring and ends with decommissioning.
Roughly summarized, Risk Management for Medical Devices according to ISO 14971 requires the following activities:
- Detection, analysis and evaluation of potential risks
- Determination of risk-minimizing measures
- Evaluation of the acceptance of residual risks
It is important that a product risk analysis maps the entire life cycle of the product and clearly and comprehensibly depicts all risks associated with the storage, use, cleaning, processing, and disposal of a product. Only if a risk analysis is manageable, a reasonable evaluation of the risks can be made.
Challenges in Risk Management for Medical Devices
Many manufacturers whose products have been on the market for many years have a risk management system that has also evolved over numerous years.
The risk analysis included in the technical documentation for these products is often based on the FMEA (Failure Mode and Effect Analysis) approach. In the course of the years and the audits, changes have been made to it due to deviations, so that now there is a virtually untamable monster, which is both extensive and complicated.
Very often the originally used technique of FMEA has been replaced by a standard-compliant technique of risk analysis without losing the technically complex parts.
And it is clear: It will not continue like this forever, but nobody quite knows how it should be done differently.
Risk Management techniques for Medical Devices
The FMEA technique is not equivalent to a risk analysis according to EN ISO 14971; it is a valuable tool for identifying hazards, which are then incorporated into the standard-compliant product risk analysis.
An FMEA is also an excellent means of analyzing a production process and thus identifying process-related steps requiring validation or process equipment requiring qualification.
All these are components of a Risk Management system. The techniques used are relatively simple if you know and master them.
Risk-benefit ratio for Medical Devices according to ISO 14971
Risk-benefit assessment is an essential part of ISO 14971. Unfortunately, it is also a recurrent source of controversy between manufacturers and notified bodies and even in European standardization bodies. The new Medical Devices Regulation and the In Vitro Diagnostics Regulation are not the only reason why the risk-benefit ratio, which is in the focus of attention, is the subject of heated discussions among colleagues as well as with the auditors.
qtec as your partner
Our experts have already guided and ultimately solved many of these discussions and are therefore happy to help shed light on the obscure aspects of risk management.
A good Risk Management system is not a burden, but a helpful tool that can be used effectively in product development and maintenance. If done appropriately, it does not create work, it will save you plenty.
With our many years of experience, we here at qtec, have already
- moderated or
numerous Risk Management systems that we have implemented and therefore are your best option.