Inherently Safer Design

Date: Monday, October 14, 2024
Time: 12pm – 1:15m PT
Audience:
– Medical device and IVD regulatory affairs professionals
– Risk Management professionals
– Systems Engineers
– Engineering management and design engineers
– Clinical Affairs professionals
Platform: Zoom

Control of risk is fundamental to producing a safe and effective medical device. ISO 14971, application of risk management to medical devices, specifies a Risk Control Prioritization that lists first, in order of effectiveness, Designing for Inherent Safety. Designing for Inherently Safer Systems can be achieved by eliminating a particular hazard and by eliminating the probability of occurrence of harm. The current situation is that ISO 14971 and its companion document ISO 24971 provide few examples and limited guidance on applying a consistent methodology for implementing inherently safer design. This webinar seeks to resolve this by providing a OCRA-DG Page 2 of 4 Rev. 05/31/2024 methodology for helping teams implement creative solutions for achieving inherently safer designs. Numerous examples using guidewords that are unique to the design of inherently safer systems are provided. Inherently safer design is applicable at all phases of design and operation, from concept to end use. However, the greatest benefit is achieved the sooner it is applied in the design cycle. Inherently safer design will be shown to be simple and elegant using the information and methodology provided with this webinar.

Learning Objectives:

1. Attendees will leave with an in depth understanding of designing for inherently safer systems.
2. Attendees will leave with specific tools, including a methodology, for leading design teams with the implementation of inherently safer design solutions.
3. Attendees will bring back a renewed understanding of the importance of applying these inherently safer design techniques sooner in the design cycle.

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About the Speaker

Jerry Valenti, P.E. (electrical)
-PRN Medical Solutions, Engineering Consultant (Design Assurance)
-30+ Years Medtech experience, Verification, Design Assurance, Regulatory Review and Submission

By formal training, Jerry is an electrical engineer and has his Professional Engineering license in California. His most recent successes include leading the submission for MDR certification for the first product launch of a Class II medical device for a local startup company. Experience includes expertise with Design Controls for FDA 21CFR820 and ISO 13485 with specific emphasis on Product Verification, and Software Quality Assurance for product software for patient monitoring devices, and patient connected therapeutic delivery devices. He is a Certified Tester (Foundation Level) from the International Software Testing Qualifications Board. Risk Management expertise includes hazard analysis and FMECA development, verification of effectiveness of mitigation controls, and Risk Management File creation and maintenance. Jerry is a member of Orange County Regulatory Affairs – Discussion Group, and American Society for Quality.

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