ISO 14971 and Medical Device Risk Management

New innovations, like robotic surgical systems and AR/VR, are constantly revolutionizing the healthcare industry. Nowadays modern medical devices have become indispensable tools in healthcare. Due to the growing medical device market and increasing software complexity, regulations governing risk management in medical devices have become more stringent in the last couple of years.  

What is ISO 14971:2019? 

ISO 14971:2019 is the international standard for risk management in medical devices. ISO 14971:2019 has been recognized as the consensus standard by the FDA and has also been harmonized with the EU MDR.  

ISO 14971:2019 details a comprehensive framework for managing the risks that are associated with medical devices. This standard specifies requirements for manufacturers to identify the hazards associated with any medical device they are developing, to analyze these risks, to plan and carry out their reduction/mitigation, and to monitor the effectiveness of these controls (mitigation efforts). Every single one of these aspects must be meticulously documented to provide evidence of an adequate risk control process.  

Two main challenges in medical device risk management 

The journey to getting regulatory clearance can be a long and laborious process. However, we know that adequate risk management saves lives, and it can help safeguard the profitability of development companies, which further adds to its significance. 

One of the main challenges is the lack of proper tooling for collaboration. Organizations are still using 15+ column Excel sheets with hundreds of risk entries. This results in no versioning or traceability. This can make it difficult to create and define the risk matrix, and/or have difficulty tying risk mitigation to design controls.  

When each business unit has its own standard operating procedure (SOP) another common challenge in medical device risk management can occur, which is organizational misalignment. In this case, every process has a different owner, and there isn’t a standardized interpretation of the Divisional Standard. There are different terms and applications. The use of different tools leads to siloed information access. Organizational misalignment also leads to update cycles being out of sync. 

Main benefits of using Codebeamer for Medical Device Risk Management 

Standardization is key to avoiding problems that could occur during an audit. Using PTC’s Codebeamer technology can help you prepare for them. With Codebeamer you can plan and schedule audits and build comprehensive, and actionable audit checklists. Using our pre-configured templates can help you hit the ground running in the delivery of regulated products. The capabilities of Codebeamer’s Medical Audit & CAPA Template support adherence to regulatory requirements, such as ISO 14971:2019, and simplify audit preparations. You can customize our templates to suit your organization’s individual needs.

Only using one tool for the whole development process allows you to be more effective in training new people on the process. With Codebeamer you can eliminate human error, due to having a fully automated process, while also documenting every step of the process and running tests to see if it’s being implemented or not.  

How does Codebeamer help with risk management & assessment?

In Codebeamer you can easily build a library of hazards. Situations will provide additional inputs based on probability. For proper assessments, these inputs need to be taken into consideration. Once risks have been assessed, you can define mitigation requirements. Codebeamer and the Medical Audit & CAPA Template provide great support for this process as well. Once your risks have been evaluated, and your root causes have been analyzed you can link the risk items to all the hazards. Once this has been done control measures show you what new requirements need to be created. After you implement these new requirements Codebeamer will show you if they are acceptable or need to be revisited. This whole process can happen in sync with your release schedule.