Stringent regulations make risk management for medical devices a difficult undertaking. But PTC’s Codebeamer solution alleviates much of that difficulty. Let’s find out more.
Like most other industries, technology has revolutionised healthcare. For example, innovations such as robotic surgical systems, augmented and virtual reality are now commonplace. However, a proliferation of new and more complex products in the marketplace has led to more stringent regulations to govern risk management.
In this article, we’ll look at one of these regulations and the challenges it brings. We’ll also look at a solution – Codebeamer from PTC.
Introducing ISO 14971:2019
ISO 14971:2019 is more than a collection of letters and numbers. It’s the global standard for risk management in medical devices, recognised by the EU and the FDA in the US.
It offers a thorough framework for managing all risks associated with medical devices. For every medical device a manufacturer creates, ISO 14971 requires them to:
- Identify hazards
- Analyse risks
- Plan and execute risk mitigation
- Monitor the effectiveness of their mitigation efforts
- Document all actions to produce evidence of a comprehensive risk management program
Medical device risk management challenges
However, complying with ISO 14971:2019 is a tricky task, not least because of two common challenges with risk management for medical devices:
- Lack of collaboration tools – Most manufacturers still use complex Excel sheets to run their risk management. These spreadsheets lack version control, traceability and can easily malfunction. When you only use Excel, it’s difficult to define the risk matrix or link risk mitigation to design controls
- Organisational misalignment – When different businesses have different standard operating procedures (SOP), it leads to different interpretations, terms and applications. You also get information siloes and poorly synchronised update cycles
Codebeamer by PTC is a solution that delivers precisely what medical device manufacturers need to alleviate these challenges – standardisation. When you have that standardisation, you can be ready for an audit, confident you’re on the right track.
It allows you to plan and schedule audits, create checklists and support adherence to all regulatory requirements, including ISO 14971:2019. Automated processes reduce instances of human error while documenting every step of the process. Customisable templates speed up the process while ensuring alignment with your organisation. In addition, because Codebeamer is the one tool that does it all, you only have to train your employees to use this solution - and you’re done.
Another excellent Codebeamer capability is its hazard library. This feature considers possible risk situations based on their likelihood, so you can assess risks, define mitigation controls and evaluate their effectiveness. All this can happen within your release schedule, ensuring your new medical device reaches the marketplace on time - with full regulatory compliance.
Find out more
ISO 14971:2019 sets much-needed international standards for the medical device industry. Meeting its requirements was never going to be easy, but with the right technology backing you up, you can smooth out the process, ensuring your devices are as safe and compliant as possible. To learn more, watch our OnDemand Webinar: Medical Device Design Control – Weaving Quality into the Digital Thread.