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

Medical Device, Medical Device Safety and Regulation, Medical Device Design,
  • Wednesday, November 06, 2024 | 1pm EST (10am PST)
  • 60 min

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, Element Materials Technology

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.

Message Presenter
Michael Kipping, Element Materials Technology

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.

Message Presenter
David Grimsey, Element Materials Technology

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.

Message Presenter

Who Should Attend?

This webinar will appeal to senior professionals involved in medical device design and manufacturing:

  • Regulatory affairs consultants (medical devices)
  • R&D Engineers / Managers
  • Innovators
  • Quality Engineers
  • Engineering Consultants

What You Will Learn

Attendees will learn about:

  • How to develop an appropriate description of the product, its intended use and technological characteristics
  • The intrinsic relationship between the product description and the array of regulations and requirements that need to be addressed for non-clinical evidence
  • Strategies for evaluating standards and regulations and work between the grey areas that make requirements applicable or non-applicable (known as conditions)
  • How the output of a regulatory compliance strategy can form the input to process development and risk management processes

Xtalks Partner

Element

Element Materials Technology

One of the world’s leading global providers of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains where failure in use is not an option. Element’s scientists, engineers, and technologists, work across a global network of over 270+ laboratories, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable and achieve market access.

Element RegNav

The future of medical device compliance: intelligent, automated, and reliable. Element RegNav guides you seamlessly through compliance and accelerates your path towards market, combining expert insights with AI, giving you a detailed picture of your safety and performance requirements.

For more information about RegNav, please visit our website, or connect with us on LinkedIn.

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