Date: 17 & 18 October 2023

Timing: 08.30 to 19.00 on Day 1/ 08.30 – 16.30 on Day 2

Venue: The Hilton Paddington, London

What’s this BSI/AAMI International Standards & Regulation Conference about?

This two-day in-person and online event will give delegates important updates on a wide range of issues affecting the global medical devices/healthcare market.

With a focus on patient safety, we’re covering most of the sector’s current ‘hot topics’ from AI regulations in Europe and the UK, to an update on the EU MDR transition proposal. Our top speakers include global regulators, clinical professionals, medical device company experts and consultants, plus representatives from notified/approved bodies and national standards bodies.

At the end of Day 1, delegates can join a networking reception.

Who should attend the BSI/AAMI International Standards & Regulation Conference?

Everyone operating in the global healthcare/medical devices space and in adjacent disciplines, e.g. Artificial Intelligence.

What will participants gain?

• the latest information on key topics impacting the medical devices sector
• expert knowledge and insights including from regulators and notified bodies
• in-person networking opportunities to establish professional contacts and build relationships
• a post-event copy of all presentations and a recording for future reference.

Agenda

Tuesday 17th October 2023

08.00 – 08.30     Registration/Coffee/Tea                            

08.30 – 08.45     Welcome & Opening remarks

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element       

08.45 – 09.30 Global conformity – what next for the UK (title to tbc)     

Graeme Tunbridge, SVP Global Regulatory and Quality, Regulatory Services

09.30 – 10.45     Artificial Intelligence/Machine Learning, AI Regulation, AI Standards – what next?        

Aris Tzavaras, BSI RS Head of AI Notified Body  

10.45 – 11.15 - Networking/Tea/Coffee break

11.15 – 12.00     Update on the EU MDR Transition proposal NB resource

Purvi Patel, BSI RS Regulatory Lead                      

12.00 – 13.00     UK Medical Device Regulations update 

Purvi Patel, BSI RS Regulatory Lead                      

13.00 – 14.15 – Networking Lunch

14.15 – 15.15     Clinical data & Clinical Investigations    

Richard Holborow, BSI RS Head of Clinical Compliance

Rachel Mead, BSI RS Clinical Regulatory Lead

Dr Amie Smirthwaite, Senior. VP, Global Intelligence & Innovation, RQM+

15.15 – 15.45 Networking Tea/Coffee break

15.45 – 17.15     FDA updates, Implementing Rule QSR/ISO 13485

17.15 – 17.20     Chair’s concluding remarks

17:30 – 19.00 Networking reception

Wednesday 18^th October 2023    

08.00 – 08.30     Registration/Coffee/Tea                              

08.30 – 08.45     Chairman’s welcome & Opening remarks            

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element       

08.45 – 09.30 Keynote address, questions & answers

Wendy Rayner, Head of NHS Circular Economy Program, Scottish Government

09.30 – 11.00Sustainability, single use, reprocessing, re-use, remanufacture, conformity assessment, circular economy/life cycle analysis             

Lena Cordie-Bancroft, BSI KS Sector Lead, Medical Devices

Heidi Barnard, Head of Sustainability, NHS Supply Chain

Clare Atkinson, Director of research & Development, NuGreen

Ami Newton, Senior Enterprise & Sustainability Manager, Medtronic

Alfred Casson tbc, Dept of Health & Social Care (DHSC), Design for Life

Samantha Smith, Director, Product Stewardship & Sustainability, Medtronic

11.00 – 11.30 Networking Tea/Coffee break

11.30 – 12.15     UK Designated Standards update, other relevant standards eg symbols, sterilisation, etc

EU Annex Z’s/Standardisation Request/Harmonisation 

Lena Cordie-Bancroft, BSI KS Sector Lead, Medical Devices

Richard Bancroft, Senior Director, Scientific, STERIS              

12.15 – 12.45     University Partnerships/Academia         

Emma Glass, University Partnerships Manager - Healthcare, BSI

Dr Irina Brass, Associate Professor, University College London

12.45 – 14.00 Networking lunch

14.00 – 15.00     Supply Chain, security of supply, multiple marks ie CE, UKCA etc, Economics,        

Helen Forsdyke, Senior Director Enterprise Regulatory Compliance, EMEA, Johnson & Johnson

Sharon Connor, Johnson & Johnson Director Environmental Sustainability

15.00 – 15.45     Innovation UK plans for future

Dr Camilla Fleetcroft, Strategy & Innovation Director, BSI

15.45 – 16.15     Data & Regulatory Science         

Rob Turpin, BSI KS Head of Sector – Healthcare

16.15 – 16.30     Final questions and close of conference              

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element       

CLOSE OF CONFERENCE  

Pricing

Member ticket: £500

Non member ticket: £1000

BS AAMI 34971:2022 helps medical AI software developers and manufacturers to manage the risks of AI in medical devices effectively and efficiently.

Richard is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Lena is the Sector Lead for Medical Devices on BSI’s Knowledge Solutions division, where she is responsible for working with industry and government stakeholders to address challenges surrounding the development and designation of medical devices standards; providing subject matter expertise and thought leadership to strengthen and promote the use of standards to support regulation; and influencing the strategy of healthcare standards through innovation and collaboration with other sectors. Her areas of focus include reprocessing of medical devices, sustainability and circular economy, and artificial intelligence and software as medical devices.

Dr. Aris Tzavaras is the Head of Artificial Intelligence NB, BSI group. He has been with BSI since 2018, worked as a BSI Senior Technical Specialist and Scheme Manager within the Active Medical Devices team. As part of his work as Technical Specialist, he has reviewed MDR and MDD active devices including AI software devices. He has more than 20 years’ experience in Medical Devices including Academic lecturing for BSc and MSc Biomedical Engineering programs. He holds a PhD in Health Informatics from City London University on Artificial Intelligence.

Rachel began her career twenty years ago as a research scientist. Since then, she has held various research and development positions in medical device companies and has experience with clinical investigations.

Joining BSI as a Technical Specialist and Scheme Manager in 2018, Rachel holds the position of Clinical Regulatory Lead, where she has a particular focus on the clinical evaluation of active medical devices.

Amie Smirthwaite is SVP, Intelligence & Innovation, for RQM+, the world’s leading MedTech service provider, offering consulting, clinical trial, lab, reimbursement and software solutions.

Amie joined RQM+ in May 2020, following 12 years at BSI, where she was Global Head of Clinical Compliance. She established BSI’s clinical compliance team and led clinical aspects of BSI’s successful designation under MDD, MDR and IVDR. Amie has been involved in numerous expert working groups within the EU, determining requirements for the interpretation and implementation of clinical evidence and postmarket surveillance, and has contributed to many MDCG and MedDev guidance documents, including SSCP, “sufficient clinical evidence”, equivalence, PMCF, and PSURs. She is contributing as Committee Expert for the European Commission Clinical Investigations and Evaluations Working Group.

Emma Glass is the University Partnerships Manager for Healthcare Technologies in the Knowledge Solutions division of the British Standards Institute (BSI). She is responsible for engaging with universities in healthcare technology research and innovation to promote participation and raise awareness of standards and standards development. Recent work includes creating and delivering an interactive workshop for Biomedical Engineering students on the value of standards in healthcare and collaborating with leading healthcare universities on innovative research projects. Prior to working at BSI, Emma launched new open-access science journals in digital health, nuclear medicine and radiology. She also authored CBP’s Big Data Focus Report in 2016 and 2017. Emma has a degree in English Literature from the University of Exeter.

Camilla bringing a wealth of knowledge and experience across the MedTech sector. After qualifying as a medical doctor, she worked for 9 years at the Medicines and Healthcare products Regulatory Agency (MHRA) and recently joined BSI to lead on strategy and innovation within the regulatory Services team. Earlier in the year she supported the UK Government as a champion for the Pro-Innovation Regulation of Technologies Review. Working hand-in- hand with Sir Patrick Vallance & Sir John Bell, the review set out key recommendations to accelerate development and deployment of emerging tech in the UK. 

Michael is Director, Medical Technologies EMEAA for Element Materials Testing which is a global testing, inspection, calibration and certification business.  Element work with a broad range of health technology businesses to proactively support them to get to market and manufacture products that are as safe as practically possible.  

Michael is a Director and President Elect of TOPRA (The Organisation for Professionals in Regulatory Affairs).  He is also involved in standards development and member of BSI committee CH/194 Biological evaluation of medical devices.

This event contributes to UN Sustainable Development Goal 3 on good health and well-being and Goal 12 on responsible consumption and production.