LTR Weekly Digest #13 - 18th November, 2023
Catch up on this week's articles: understanding reasonably foreseeable misuse, application of digital technologies and a risk-based approach to auditing quality systems.
Dear colleagues, hello! 👋
➡️ISO 14971 requires medical device manufacturers to identify and document reasonably foreseeable misuse during risk analysis. Reasonably foreseeable misuse is more than just use-error. It also includes intentional acts of misuse and off-label use. However, current industry practice focuses almost entirely on use-error as part of the usability engineering process according to IEC 62366-1. As a result, risk associated with misuse largely remains uncontrolled.
This article clarifies the full scope of reasonably foreseeable misuse using illustrative examples, and offers practical tips for managing the risk associated with such misuse.
➡️Digital technologies are being rapidly deployed in medical applications. While there is new excitement about the potential to solve some of our most challenging medical problems, there is also a lot of uncertainty in the regulatory approach to devices using based on these technologies.
In this Let’s Talk Risk! conversation, Pascal Werner shares some of the challenges and opportunities in developing digital technologies for medical applications.
➡️Medical device manufacturers operate under a heavy load of audits and inspections. Even the regulatory authorities across the world are recognizing the heavy burden of multiple audits and inspections on manufacturers, which take away resources and time that could otherwise be invested in new product development and continuous improvement activities.
There is a movement in the regulatory compliance world to adopt a least-burdensome approach for regulatory decision making throughout the device lifecycle. In this context, the auditing practices in the industry are moving from an element-based approach to a risk-based approach.
Quick announcement
LTR is taking a break next week. Happy Thanksgiving!
I want to thank you for your support and wish you a joyful time with family and friends. We will resume our weekly publication schedule starting Nov 27, 2023.
Weekly Knowledge Challenge #11
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The statement “since we practically cannot do anything about off-label use of our medical device, there is no need to include it in our risk analysis”, is FALSE.
Here is this weeks’ knowledge challenge.
1-Question Feedback Survey
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