On September 4th and 11th, Medical Innovation Xchange (MIX) hosted training for ISO 14971:2019 Risk Management for Medical Devices, held both in-person and virtually to support resident and affiliate companies.
What Is ISO 14971:2019?
ISO 14971:2019 is the internationally recognized standard for risk management in medical devices. Training manufacturers to better identify, evaluate, control, and monitor risks throughout the product lifecycle.
Who Participated?
MIX resident and affiliate companies that attended include Hyivy, FluidAI, Intellijoint Surgical, Vena Medical, Vessl Prosthetics, Tenomix, Cobionix, Revolve Surgical, and Exact Imaging. Their participation reflects MIX’s commitment to upskilling its workforce and ensuring that every team member has access to up-to-date safety and compliance standards.
Why This Training Matters
This training was requested through the Quality Assurance and Regulatory Affairs MIXer event, one of many MIX community events provided to support professional development and continuous learning. ISO 14971 training is essential for compliance with FDA regulations and global market access.
Key Takeaways from Attendees
The training provided by Intertek provided insights throughout the session. “Bill kept it highly engaging and tied a lot of his auditing experience into the course,” said Rupreet Bhogal. Participants were able to gain a deeper understanding of the importance of a well-structured Risk Management File and the lifecycle approach to risk management, “Risk management is a living process that spans the entire product lifecycle (design through post-market),” emphasized Rupreet. He also noted, “Controls should always be proportionate to risk,” and that “Auditors often ask early on about adverse events, recalls, or advisory notices.”
The hands-on exercise helped reinforce concepts: “Key course exercise: building a simple risk matrix from hazard ID through to controls and residual-risk acceptability. The activity expanded as new concepts were introduced and sparked some good group discussion.” – Rupreet Bhogal
Kristina Arseneault emphasized: “ISO 14971 provides a framework not just for conformance, but for building safer and more effective devices through proactive risk thinking.”
As the medtech landscape evolves, MIX remains dedicated to empowering its residents and affiliate companies with the knowledge and resources they need to succeed. This is achieved by equipping teams with the tools to navigate risk with confidence. MIX continues to offer a culture of safety, compliance and upskilling across its community.
Interested in future training opportunities or joining the MIXer program? Stay connected with MIX for upcoming sessions and resources.
