BSI/AAMI International Standards and Regulations Conference

Recorded: 29th and 30th June 2022 (13.00 – 17.30 BST on both days)

What’s the BSI/AAMI International Standards and Regulations Conference about?

With an emphasis on regulatory compliance and patient safety, this year’s virtual conference will examine the continuing changes in the global medical devices market, post-pandemic. In particular, we’ll be focusing on:

• Devices’ regulation in a global market
• UK and EU medical device and IVD regulations
• How the MHRA is prioritizing patient safety
• Sustainability in medical devices
• Connected digital health and AI
• The FDA’s new Quality Management System Regulation

Who should attend the BSI/AAMI International Standards and Regulations Conference?

Healthcare and medical device manufacturers, specifically:

• CEOs
• Regulatory affairs
• Quality affairs
• Designers
• Engineers
• Compliance officers

What will participants gain?

• First-hand information and perspectives from expert speakers
• Current news and insights on key medical device issues
• A post-event copy of all presentations and a recording of the webinar

Recorded: 29 June 2022 (13:00 - 17:30)

The event will explore medical devices regulation in a global and UK market and provide an update on UK Designated Standards, relationship of standards and “State of the Art”.

Recorded: 30th June 2022 (13:00 - 17:30)

This webinar will talk over the innovation in enhancing patient safety and evolution of assurance services during pandemic. It will also cover FDA Final Rule adoption of ISO QSR’s/13485.

Eamonn Hoxey, is a technical author, trainer and consultant in life science areas including regulatory compliance, quality management, sterility assurance and standards development. Eamonn worked for Johnson & Johnson for 17 years in positions of increasing responsibility for Quality and Regulatory Compliance including Vice President of Compliance for J&J’s medical devices companies. Prior to joining J&J, Eamonn spent 16 years with the UK Medical Devices Agency, including six years as Head of Device Technology and Safety.

Eamonn is currently chair of CEN TC 204 ‘Sterilization of medical devices’ and past chair of ISO TC 210 ‘Quality management and related general aspects for medical devices’ and ISO TC 198, ‘Sterilization of Healthcare products’. He is past chair of the Board of Directors of AAMI.

Dr Hoxey graduated as a Bachelor of Pharmacy and has a Ph.D. in Pharmaceutical Microbiology from the University of Bath. He was designated a Fellow of the Royal Pharmaceutical Society of Great Britain in 2004 and an AAMI Fellow in 2022. He received the BSI Wolfe-Barry medal in 2016 for his contribution to standards development.

Graeme is Senior Vice President, Global Regulatory and Quality, Medical Devices at BSI. He has responsibility for BSI’s regulatory compliance to undertake a range of global medical device certification and accreditation activities. 

Prior to joining BSI, Graeme was Director of Devices at the UK Medicines and Healthcare products Regulatory Agency (MHRA), where he was responsible for ensuring the safety and performance of medical devices in use in the UK. Graeme first joined the MHRA in 2011 and spent much of his time at the MHRA negotiating and implementing a package of measures to strengthen the regulation of medical devices. 

Graeme was a civil servant for nearly 20 years and spent his early career working on healthcare policy. He has previously held Deputy Director roles at the Department of Health and Social Care and spent 18 months as Private Secretary to the Secretary of State for Health. 

Graeme has a Master’s degree in biochemistry from the University of Oxford. 

Jayanth is a Regulatory Director within BSI and the Head of the Notified Body for Medical Devices. He is responsible for the regulatory oversight of Medical Devices Notified Body activities, and wider BSI strategy, policies, procedures, and documentation to meet the various legislative and designation requirements. He has held other roles such as the Head of the UK Approved Body, Head of Training, Technical Team Manager, Technical Specialist & Scheme Manager prior to the current position.

Prior to joining BSI, Jayanth was the Chief Scientist at a start-up medical device company developing innovative soft tissue repair and replacement therapies. He holds a PhD in bioengineering from the University of Leeds.

Helen Forsdyke has been part of for Johnson & Johnson for over 20 years and is currently the Senior Director, Regulatory Compliance, partnering with the Johnson & Johnson commercial entities in EMEA and distribution centres globally to ensure End-2-End Quality Compliance.  In this role, Helen is responsible for ensuring a proactive approach to Quality Management, working to mitigate potential compliance risks, and specifically working with the Commercial Quality teams to focus on customer requirements.  As part of the J&J Regulatory Compliance organization, Helen has responsibility for monitoring the external environment, with focus on changing regulations impacting Quality & Compliance, partnering with Regulatory, and Government Affairs in advocacy, and then working with the business to implement changes.

Helen has a strong background in Quality Management Systems, working in Pharmaceutical, Medical Device and Combination Product areas to gain the widest experience of the applicability of Quality System requirements to our products.  She has hosted multiple Health Authority and Notified Body inspections under a variety of regulations, specifically for Medical Devices this list includes ISO13485 & ISO9001, USA FDA QSR 820, EU MDR/MDD/IVD, and MDSAP.  More recently, Helen has led the Regulatory Compliance activities to ensure inspection readiness for the EU Medical Devices Regulation at the Legal Manufacturing sites globally, including the execution of a readiness internal audit program at all sites ahead of the Notified Body certification audits.  Helen has presented at several industry conferences on the practical application of the EU MDR for a large-scale manufacturer, sharing experiences and lessons learned in meeting the new regulatory regime.  Currently, she is working with the business to integrate the requirements of multiple changing regulatory requirements including UK Medical Devices Regulation, Swiss Medical Devices Ordinance and Eurasian Medical Devices Regulation.

Helen has a degree in Applied Biology from The University of Hertfordshire, UK, and has a background in industrial microbiology.  She started her Johnson & Johnson career in 1998 as the site Microbiologist, with responsibility for a large-scale gamma irradiation plant alongside both steam and aseptic manufacturing processes.  She has held positions of increasing responsibility within J&J, including being the Management Representative for a device manufacturing Quality System, leading Quality Operations, Regulatory Affairs, Quality Laboratories, Design Quality and Supplier Quality Teams.  Helen is a member of the J&J Microbiological Quality & Sterility Assurance Leadership Team as the Compliance partner, maintaining her passion for microbiology.

Lena Cordie-Bancroft 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 resolve issues surrounding the development and designation of medical devices standards; providing subject matter expertise and thought leadership to strengthen and promote the use of standards; and influencing the strategy of healthcare standards through innovation and collaboration with other sectors.

Lena was previously president and principal consultant at Qualitas Professional Service, where she worked with medical device companies to implement quality management systems, international regulatory requirements related to quality systems, risk management, labelling and Unique Device Identification (UDI) requirements. She is actively involved in AAMI Sterilization Standards, ISO/TC 145, ISO/TC 198 and ISO/TC 210 work groups, and is the convener of ISO/TC 210 WG3. She is also involved in Regulatory Affairs Professionals Society (RAPS), and serves as the chair for the Twin Cities Chapter, is a leader of the UK Local Networking Group, a member of the RAPS European Committee (REC), and a member of the RAPS Awards Committeee. Lena is involved in a number of ABHI groups and is the chair of the ABHI Decontamination Group. She is co-chair of the Kilmer Regulatory Innovation Team, chairs the AAMI Awards Committee and serves on AAMI's Nominating Committee and Editorial Board.

Camilla has a wealth of experience in both clinical and regulatory spaces. Since qualifying as a doctor, she worked at the MHRA for over 8 years, with a short time spent at SGS. In her role, as Deputy Director for Innovative Devices, she led the development of the future UK regulations for medical devices following Brexit, and is involved with policy makers, regularly interacting with ministers and decision makers.

Prior to that Camilla was the Head of Clinical Investigations and Evaluation at MHRA and before the UK exit from the EU, she represented the MHRA in the EU Clinical Investigations and Evalution working group, leading the drafting for MDCG 2020-05 on Equivalence and working on the practicalities & challenges of the implementation for the MDR requirements for CIs and Clinical Evalution in the UK.

Judith Prevoo is a Regulatory Lead for BSI The Netherlands Notified Body and she is responsible for the regulatory oversight of medical devices Notified Body strategy, policy, procedures and documentation to meet the various legislative and designation requirements. Before joining BSI in 2018, she gained over 13 years` experience in the In Vitro Diagnostic medical device and pharmaceuticals industries in both scientific and Quality Assurance roles.

Steve has 30 years experience of in vitro diagnostic medical devices. He is Ex-MHRA IVDR senior regulatory policy manager and Former Chair of European Commission's IVD Working Group.

He has experiences in implementation of IVD Regulation (2017/746): performance evaluation; companion diagnostics; software/bioinformatics; classification; health institution exemption; conformity assessment; reference labs, and so on.

Steve is a lifelong learner, Chartered Scientist, Fellow of the Institute of Biomedical Science, Fellow of The Organisation for Professionals in Regulatory Affairs.

Pamela Arora is a dynamic Business Leader and experienced Board Member with expertise in healthcare technology and health facilities operations. She brings a successful track record of executive leadership in strategy development and execution, project management and employee engagement. Currently, as the President & CEO of the Association for the Advancement of Medical Instrumentation (AAMI), which advances the development and safe and effective use of medical technology, Pamela champions a culture of openness and innovation, identifying and bringing together key constituencies to solve complex issues, and balancing domestic and international points of view.

In this role, Pamela also serves as AAMI’s principal spokesperson, maintaining regular contact with member organizations, regulators, industry, media and the public, including relationships with the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS) and other key regulatory agencies to ensure inclusion and further establish AAMI as an expert reference for those organizations.

This follows her time as SVP CIO Children’s Health in Dallas, TX, one of the largest pediatric non-profit health systems in the U.S. In this role, Pamela worked with leadership to provide highly innovative, efficient, safe and comprehensive technology systems and solutions that enhance the experience of patients, families, faculty and staff.

Pamela has extensive Board and community/industry leadership experience, including serving on the HIMSS North America Advisory Board, the AAMI Board, and HITRUST Board.

Amanda Benedict, MA, CStd, is Vice President, Standards a role assumed in 2020 after joining AAMI as a Standards Director in 2015. She has oversight of the strategic and operational functions of AAMI’s expansive and dynamic Standards program and portfolio. She managed the national and international work program for the AAMI Sterilization standards portfolio from 2015 until 2022, which included serving as the Secretary and U.S. TAG Administrator for ISO/TC 198 on sterilization of health care products, and now leads the AAMI and ISO standards activities in quality management for medical devices.

Ms. Benedict holds a Bachelor of Arts in psychology and a Master of Arts in education and human development from the University of Maryland, College Park.

Over 9 years regulatory experience at the MHRA and EMA responsible for development of new strategic directions and extensive experience in the completion of key regulatory reviews, assessment of risk management plans, type II variations and associated amendment of product information and signal assessment across a range of products.

2 years 9 months experience as Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust responsible for developing strategic priorities for this scientific area, leading a team providing advice to potential applicants, supporting a large number of Wellcome funded senior investigators, Wellcome funded research centres and major Wellcome investments such as UK Biobank.

10 years experience as academic Senior Lecturer/Lecturer in a top UK Cardiovascular Research Unit at King's College, London. 5 years experience as a post-doctoral fellow in London and the USA.

Cormac launched the independent product development consultancy Kestrel Technology Consulting in 2017, following a 27 year career in product development with an emphasis on medical device development consultancy. He has worked on numerous drug delivery, ophthalmic, surgical, medical and diagnostic projects and this is still the main business of Kestrel today. In parallel he has been working on cross-sector standards and best practice guidelines for sustainable design and manufacture since the early 2000’s and is now looking to apply this knowledge where it’s most needed in the medical sector.

Cormac launched the independent product development consultancy Kestrel Technology Consulting in 2017, following a 27 year career in product development with an emphasis on medical device development consultancy. He has worked on numerous drug delivery, ophthalmic, surgical, medical and diagnostic projects and this is still the main business of Kestrel today. In parallel he has been working on cross-sector standards and best practice guidelines for sustainable design and manufacture since the early 2000’s and is now looking to apply this knowledge where it’s most needed in the medical sector.

Cormac also heads up the committee on the application of BS 8887 to sustainable design and manufacture in the medical sector.

Ahmad brings more than 15 years of experience in the Assurance industry, focusing on Auditing & Certification, Training, and Product Testing and Conformity services.

Ahmad is a member of BSI’s Assurance Executive team and currently the Global Director of BSI Assessment and Certification Services, based out of BSI’s HQ in London. In addition, Ahmad leads the Business Development function for Assurance services focusing on BSI’s priority sectors and themes in particular Sustainability and Digital Trust. Prior to that Ahmad held various positions within BSI Group in several business lines and regions. Ahmad is a frequent speaker in national, regional, and international forums, and an advocate of standards, enabling trust and organizational resilience. Ahmad holds a Masters degree in International Business, and a degree in Management Information Systems.

Rob Turpin joined the British Standards Institution (BSI) in 2001 and is currently Head of Sector for Healthcare in the Knowledge Solutions stream.  He leads on the strategic standardization approach for the role that BSI has in supporting policy, productivity and innovation in the healthcare system.  His key area of focus include medical technology, NHS policy and innovation and population health. 

Previously, Rob has been involved in managing national and international standards development programmes across a variety of subject sectors.  He has a degree in Chemical Engineering from the University of Teesside, UK.

Johan leads Software Group within the Medicines and Healthcare products Regulatory Agency (MHRA). Software Group are responsible for most aspects of regulating software as a medical device (AI included) and work to ensure these devices are acceptably safe and deliver for patients. He was a co-author of Good Machine Learning Practice for Medical Device Development, has been involved in the development of various reporting standards for AI such as DECIDE-AI, and represents the UK in several international fora such as the AI Medical Device Working Group at the International Medical Device Regulators’ Forum. Johan has four degrees, the last being a BA in Law from Wolfson College, University of Cambridge and is an Associate with Hughes Hall, University of Cambridge.

Allison Gardner is an expert in AI and Data Ethics with interests in health technology, algorithmic bias, HCI, diversity and inclusion. Allison works for the AI Multi-agency Advisory Service with NICE addressing cross-regulatory policy. She is an experienced educator and is an (Hon) Senior Research Fellow at Keele University. She co-founded Women Leading in AI and is CEO of AI Aware Ltd. Allison sits on a number of standards committee including ISO/IEC SC42 UK National and CEN-CENELEC JTC21 as a ForHumanity Fellow. Allison is a renowned speaker on AI ethics, with several media appearances including as a TEDx speaker.

Currently retired. Scott was previously the International Regulatory Affairs and Quality Compliance Director at 3M in the Health Care Business Group. 3M Health Care provides clinical solutions for infection prevention, skin and wound care, oral care, and food safety globally. HIs role was to manage a global team assuring regulatory and quality management system (QMS) compliance for health care products.

To support better patient access to health care products and development of the profession globally, Scott also serve as:

• Convener of ISO TC210 Working Group 1 responsible for ISO 13485:2016 – Medical devices -- Quality management systems -- Requirements for regulatory purposes
• Adjunct Professor in St. Cloud State University - Masters degree program for Regulatory Affairs and Services
• Lead Industry Advisor to the Global Harmonization Working Party’s (GHWP) Technical Committee
• US Food and Drug Administration (US FDA) - Good Manufacturing Practice ( GMP) Panel - Industry Representative

Professor Miller is a respected international consultant in health informatics and eHealth strategy and systems. He has spent his entire career in the information technology domain, with the last 18 years dedicated to working on eHealth innovation and large and complex eHealth programmes around the globe.

Michel has worked in healthcare transformation for NHS England, Supreme Council of Health in Qatar, Queensland Health – Australia, MoH KSA, MoH Singapore and many other nations.

Michael is a member of the WHO Digital Health Technical Advisory Group (DHTAG) Roster of Experts and the WHO (Europe) – “Committee for Digitalization and Health Information Systems Standards”. He is an advisor for the British Standards Institute (BSI) on healthcare standards and systems technology and an advisor to NHS England- NHSX – Blueprint programme for eHealth projects reviews, including Integrated Care System (ICS) projects. Additionally, Michael has recently been appointed as a special advisor to the NHS 40 New Hospital Programme. He is also CEO of the Care Innovation Corporation, which develops advanced telemedicine systems to manage chronic conditions using cutting-edge wearables and AI.