Medical Device Safety: The Next Frontier

During the COVID-19 pandemic, there was global demand for engineered medical devices and a shortage of critical products, including ventilators. Many countries, including the UK, resorted to developing new products or scaling up existing ones to meet their needs.

Given the critical urgency for products, regulatory processes and expectations had to be adapted. The expert speakers were involved in the UK Ventilator Challenge and one key challenge was understanding the non-clinical safety and performance requirements.

They observed first-hand the collaborative efforts of extraordinary individuals who had a broad range of backgrounds: Clinicians, Design Engineers, Test Engineers, Quality Engineers, Regulatory Affairs Specialists, Scientists and academics.

In this webinar, the expert speakers will focus on an artificial intelligence (AI)-based platform designed to navigate these complex requirements, enabling the development and maintenance of safe and high-performing medical devices. This approach leverages the foundation of international safety and performance requirements and establishes state-of-the-art practices and user-defined characteristics derived from the intended use and technological features of medical products.

From defining product characteristics to understanding the performance, safety, usability and functional requirements, the platform helps create comprehensive design and development plans. These plans ultimately facilitate submissions to regulatory authorities, notified bodies and stakeholders, providing evidence that all necessary requirements have been met.

This project represents not just a technological advancement but a profound commitment to improving the safety and efficacy of medical devices, ensuring better outcomes for patients and healthcare providers worldwide.

Register for this webinar today to discover how an AI-based platform can improve medical device safety 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.

Message Presenter

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; and has spent ~7-years helping start-ups launch safe medical devices as part of MHRA and Innovate UK.

Message Presenter