Summary

“Risks occur. They happen but they don’t exist… hazards do.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS & Audit Specialist and risk management trainer with deep experience across ISO 13485 auditing, ISO 14971 risk management (including usability), and certification/accreditation perspectives.

Our conversation is deliberately informal and highly practical. We explore why many teams get stuck in the mechanics of risk tools (especially large, bottom-up FMEAs), and how a shift toward hazard-first thinking can make risk management more tangible, especially for startups, early-career professionals, and teams working on diagnostic and software-driven devices.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:01 Introduction to Jean’s start in risk management02:45 Linear standards vs. real-world complexity05:20 Indirect harm in diagnostic and AI devices07:10 Risk management for start up and early career professionals10:30 Risks don’t exist, hazards do 13:20 Role of examples in risk management16:45 Risk information outside of risk management team 18:00 Why FMEAs fail at the executive view20:20 Risk management competence development21:00 Seek to be understood 23:40 Teaching risk without jargon26:40 From getting it right to not getting it wrong

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Suggested links:

LTR: Why FMEA Alone is Not Sufficient for Risk Analysis.

LTR: Three Pillars for Defining Your IVD Risk Management Strategy.

LTR: Focus on Intended Use for IVD Risk Management.

Key Takeaways

* When just starting with risk management, begin with hazards: they are tangible and controllable; “risk” is an outcome.

* Standards provide structure, but real-world risk is non-linear and contextual.

* Diagnostic and AI devices shift risk focus from physical harm to information.

* The instructions for many legacy risk tools (like FMEA) were built for projects and missions, not full lifecycle thinking.

* Large FMEAs, even summarized, do not provide meaningful executive insight.

* Jargon blocks learning; effective training must be adapted to experience level.

* Risk capability evolves: from first learning to get it right, to continue training to not being able to get it wrong.

Keywords

Hazards, Hazardous Situations, ISO 14971, ISO 13485, Risk Management Training, FMEA Limitations, Diagnostic Device Risk, Usability Engineering, ISO 62366-1, Systems Thinking, Benefit–Risk, Risk Communication, Startup QMS

About Jean Blom

Jean Blom is Netherlands-based QMS & Audit Specialist and Quality Manager (Medical Devices) with extensive experience guiding teams through ISO 13485 quality systems, auditing (ISO 19011), and ISO 14971 risk management, including usability. He has served as a Technical Assessor/Technical Expert for ISO 17021-1 accreditation activities related to ISO 13485 certification bodies and has supported global QMS compliance across multiple markets and device types.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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