Navigating MedTech regulations in the era of digital revolution
The regulatory ecosystem can be daunting for anyone wishing to access the healthcare marketspace. To support innovators to navigate the complexities of healthcare regulation, Eastern AHSN has teamed up with regulatory experts from Global Regulatory Services Ltd and Med-Di-Dia Ltd and to bring you a masterclass on the topic “Navigating MedTech Regulations in the era of Digital Revolution”. The focus of this Masterclass will be MedTech and digital healthcare solutions.
Attendees will learn about the regulatory pathways applicable to MedTech products and the requirements needed to plan an effective regulatory roadmap. The Masterclass will touch on the ever-increasing interest in the NHS marketspace as well as outlining key standards which need to be considered in order to succeed within the digital healthcare market.
Learning objectives
- Understand why a regulatory strategy underpins future success
- Overview of the regulatory requirements when using the UK as a launchpad into Europe and beyond
- Understand the steps required for innovations that aim to provide ‘Software as a Medical Device’ (SaMD)
- Understand how Medical Device Regulations can apply to Software
- Introduction to the difference between Europe and the UK – Medical Device software
- Introduction to demonstrating compliance to Essential Requirements (ERs) and General Safety and Performance Requirements (GSPRs)
Our Speakers:
Jenny Norman - Innovation Lead/Advisor - Eastern AHSN
With a background in healthcare for the past 8 years across a variety of roles in both Primary and Secondary Care, Jenny is passionate about improving outcomes for patients and healthcare workers across the system. Her role includes organising and planning educational events for innovators and SMEs as well as managing Eastern AHSNs innovator portfolios to support and engage with our NHS stakeholders, both regionally and nationally.
Tara Fahy – Regulatory and Quality Consultant – Med-Di-Dia Ltd.
Quality and Automation engineer and a Quality Manager with excellent technical knowledge, leading and supporting teams in rapidly growing MedTech, aerospace, pharma, and food Industries. With a career spanning over 20 years, her achievements have included: successfully designing and implementing quality management systems achieving accreditation under ISO 13485:2016; using lean tools and techniques to drive continuous improvement to meet all key performance metrics; worked closely with operations teams to ensure the provision of high quality and effective products; full responsibility for liaising and lead contact with regulatory authorities; assessing and implementing requirements as per the new EU Regulations. Design and implement PRRC and EU authorized representative processes within the Med-Di-Dia family. Diploma and degree qualified in Quality engineering.
Greer Deal – Co – Founder - Global Regulatory Services Ltd.
A Fellow of the Chartered Management Institute and a member of The Organisation for Professionals in Regulatory Affairs (TOPRA), Greer has over 30 years’ experience in the life science sector. In 2007 she co-founded an independent consultancy, Global Regulatory Services (GRS), with a focus on regulatory affairs and quality compliance. Then more recently, spun out Med-Di-Dia to focus on MedTech regulations. She is frequently asked to speak at seminars on a wide variety of topics and increasingly on the changing regulatory scene for Medical Device companies in the UK and Europe. She is passionate about regulatory affairs being recognised as an asset which adds value to a company’s bottom line and ensures only good quality, safe products enter the market.
David Didsbury – Associate Consultant – Med-Di-Dia Ltd.
David has over 40 years of experience in the medical device industry, a degree in Biomedical Electronics and an MBA in Technology Management. He has held multiple roles in SMEs and multinationals, with significant experience and expertise in international medical device regulations and quality requirements. He has helped SMEs successfully introduce FDA/ ISO 13485 compliant systems, including Design & Development processes (IEC 60601 and IEC 62304, firmware, PC, cloud and mobile apps.).
Paul Butcher - Associate Consultant - Global Regulatory Services Ltd.
Paul brings over 35 years of computing experience gained across a number of industries including Engineering, Banking, and Finance Data Management, where he has designed and delivered secure computer infrastructure solutions for both physical and Cloud based virtual systems. For the last four years he has been using a more data-focused approach to Cybersecurity and Vulnerability Scanning. All of his Cybersecurity, Information Management and Design skills have easily transferred over to help implement secure systems and IoMT, now in the medical device industry.
Marie Gallagher – Regulatory and Quality Consultant – Med-Di-Dia Ltd.
Quality/Regulatory professional with a proven track record of being a successful team leader and member, leading projects, and individual tasks to meet customer and business requirements while ensuring patient safety. She has worked closely with a number of regulatory agencies and notified bodies communicating effectively on behalf of Medical Device Companies. Her expertise includes Medical Device Regulation (MDR) remediation activities ensuring compliance with the applicable regulatory requirements.
