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Medical device risk management Tip 1 – What to study to understand medical device risk management

When participating in a discussion about ISO 14971 with Monir El Azzouzi, I mentioned suggestions about what to study to understand medical device risk management, here are the suggestions divided by topics (there are some other important topics, but the below are the basic ones, in my opinion).

1 – Decision theory

First, it’s important to understand decision theory and how risk management fits together with decision theory. An initial reading I suggest is this document – Decision Theory A Brief Introduction (you can find it in several places online, such as this – https://people.kth.se/~soh/decisiontheory.pdf).

One book on decision theory I would recommend is:

– Decision Making in Action-Models and Methods (https://www.amazon.com/Decision-Making-Action-Cognition-Literacy/dp/0893919438)

2 – Product liability

Next, it’s important to understand the role of product liability and how risk management fits in. One initial reading I suggest is this: Product liability – Product Safety – Risk Management – https://www.insafetyconf.com/media/PDF/safety_conf_2014/materials/SM3.pdf).

One book I would recommend is: 

– Lawsuit! Reducing the Risk of Product Liability for Manufacturers (Amazon link)

3 – Product lifecycle

Again, how risk management fits in the product lifecycle scheme. 

The book I recommend is:

– Product Policy: Concepts, Methods and Strategies (https://www.amazon.com/Product-Policy-Strategies-Addison-Wesley-Marketing/dp/0201083434)

4 – Reliability engineering

Now, going into the technical details of risk management, first, you need to have a great understanding of reliability engineering and method (this would also include a good grasp on probability and statistics for engineering, too)

One book I would recommend is: 

– Introduction to Reliability Engineering, 2nd ed (https://www.amazon.com/Introduction-Reliability-Engineering-2nd-ed/dp/B010GO3GXM)

5 – Risk management concepts – As a policy

For the initial risk management concepts, after you study all the above, I would suggest the usual classical texts to understand risk management in the high-level, policy view:

– Reducing risks, protecting people HSE’s decision-making process (and basically all HSE resources) – https://www.hse.gov.uk/risk/theory/r2p2.pdf

– The tolerability of risks from nuclear power stations – http://www.onr.org.uk/documents/tolerability.pdf

– Risk Assessment in the Federal Government – Managing the Process – https://www.nap.edu/catalog/366/risk-assessment-in-the-federal-government-managing-the-process

– Government Policy on the Management of Risk – Volume I: Report – https://publications.parliament.uk/pa/ld200506/ldselect/ldeconaf/183/183i.pdf

6 – Risk management concepts -Technical 

For the technical concepts I would suggest the following classical texts:

– System Safety Scrapbook (and anything else from P. L. Clemens) – http://isss-tvc.org/scrapbook.pdf

– System Safety and Risk Management – A guide for engineering education – https://www.cdc.gov/niosh/docs/96-37768/default.html

One book I would recommend (I use the first and second chapter as the conceptual part of my risk management training):

– Probabilistic Risk Assessment and Management for Engineers and Scientists (Second Edition) – https://www.amazon.com/Probabilistic-Assessment-Management-Engineers-Scientists/dp/0780360176

7 – ISO 14971 and ISO TR 24971

Thennnnn you can read the standard and the guidance, and there will be probably only a few questions left (that you can check back in the literature).

One Comment

  1. Edwin Bills Edwin Bills April 23, 2020

    One book I can recommend was recommended by one of my connections, ENGINEERING A SAFER WORLD Systems Thinking Applied to Safety; by Nancy G. Leveson; 2011; MIT Press. I found it at Amazon. Systems Safety especially applies today with interconnected medical devices and combination products where devices, drugs, and biologics form a system. We need to look at risk management from the perspective of the patient / user, looking back at the system providing treatment and diagnosis, and not just the individual components and the device.

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