Medical Device Safety: Navigating Regulations and Standards to Determine Non-clinical Requirements

The process of understanding exactly what regulations and standards apply to engineered medical products is highly complex and based upon a system known as the ‘generally acknowledged technological state of the art’.

To understand the myriad of requirements, regulatory, technical, engineering and quality professionals have to navigate a complex network of regulations, standards and other documents that set out the key functional, performance, safety and user requirements. In an ever-changing world, this creates a high degree of uncertainty and often is based upon tribal knowledge rather than systematic and critical evaluation.

This webinar will focus on how the intended use, technological characteristics and risk classification of a medical device relates to standards. The attendees will gain insights into how a software tool like Element RegNav can increase speed and accuracy in identifying relevant requirements. This in turn creates the necessary trust and assurance in giving greater confidence in product development and regulatory submission, underpinned by robust non-clinical evidence.

This webinar will be particularly useful for attendees who are developing a medical product or have never interacted with a regulatory agency and/or conformity assessment body. Moreover, this webinar is of benefit to contract manufacturers who must follow a systematic process to ensure that medical devices meet specified requirements.

This webinar is Part 2 of Element RegNav’s medical device safety series. Part 1 – Medical Device Safety: The Next Frontier (October 23, 2024)

Register for this webinar to discover how medical device safety can be improved by streamlining the development and regulatory process for medical devices.

Speakers

James Pink, Director, Medical Technologies, Element Materials Technology

James Pink is Element’s Senior Director of Global Medical Technology Testing, Inspection and Certification. He is an accomplished technical expert with a 25-year career in medical technology product safety and market access and has audited hundreds of medical device companies as part of the European CE marking requirements.

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Michael Kipping, Director, Medical Technologies, Element Materials Technology

Michael Kipping is Element’s Director of Medical Technologies in EMEAA. He has over 17 years of experience, working at companies like Boston Scientific & BIOTRONIK. He has spent ~7 years helping start-ups launch safe medical devices as part of MHRA and Innovate UK.

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David Grimsey, Director, Product & Design, Element Materials Technology

David Grimsey is Element’s Director of Product & Design and leads the development of our RegNav software. David has a background in developing data science-led products that solve real-world problems.

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