Only when a medical device has been fully developed and is ready for market launch should manufacturers concern themselves with risk management. Right? Wrong! Risk management is an essential requirement for every medical device – before development, during the process, at market launch and beyond. Which steps in the development process are central and what you should consider in the risk analysis according to EN ISO 14971 – we describe it to you.
The EU standard ISO 14971 is central to the risk management of medical devices. It describes the application of risk management to medical devices and thus a process to ensure that risks are known, controllable and acceptable compared to the benefits.
First and foremost is the awareness of risk management. Manufacturers should prioritise and document this process from the beginning. ISO 14971 describes exactly how the risk management process should be set up. According to this, the process must include the following points:
The focus of risk management for medical devices is undoubtedly on the safety and health of patients and users. Every development therefore begins with a comprehensive analysis of possible risks, even before the first prototype is ready for demonstration. However, a well-documented risk analysis is not only indispensable for avoiding possible dangers for patients and users.
Identifying errors or unfeasible processes in production at an early stage optimises the product, saves time and thus reduces possible modification costs for manufacturers. It is important that the analysis covers the entire life cycle of the medical device and identifies all risks associated with use, maintenance and disposal. Only if all possible risks are prepared and documented in detail can a standard-compliant assessment of the risks be made.
Two procedures have become widely established for risk analysis: Preliminary Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA). While PHA follows the “top-down” principle as an approach – i.e. it becomes more and more specific from the general – FMEA uses a “button-up” method and works its way from the concrete to the general.
More differences?
Read more about it now in our blog.
One certainty remains in the development of medical devices: Risk management is not static and therefore never complete. ISO 14971 requires post-market surveillance – and this always brings to light new results and findings about the medical device. The documentation effort for manufacturers therefore remains even after the product has been placed on the market.
How can the risk management process be simplified for manufacturers of medical devices? The BAYOOSOFT Risk Manager supports you as the world’s leading software solution. All relevant information is recorded in a clearly structured environment, stored centrally in an audit-proof manner and linked dynamically in a fine-granular manner. In this way, you avoid redundant data storage. Reports are generated with the most up-to-date data at the touch of a button.
There are some special features to consider in the risk management of medical software. IEC 62304 applies here for the development and maintenance of medical device software. Read here how you as a manufacturer can implement the regulatory requirements, avoid unnecessary effort and achieve conformity.
Svenja Winkler
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Franziska Weiß
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General safety and performance requirements: What applies to medical devices... 
