BSI/AAMI International Standards and Regulation Virtual Conference

BSI/ AAMI International Medical Device Standards and Regulation Conference

BSI/ AAMI International Medical Device Standards & Regulation Conference

David Bell - Director of Standards Policy, British Standards Institution (BSI)

David Bell is Director of Standards Policy at the British Standards Institution (BSI). He heads a team of 24 which is responsible for BSI's input to the international and European standards bodies, ISO, IEC, CEN and CENELEC on technical and policy issues. In addition, David manages BSI's institutional relations with national and regional standards organizations, as well as relations with British industry, UK government and with key stakeholders, including consumer and public interest groups.

An economist by training, with a diploma in management, David has been at BSI for over 20 years, overseeing a number of European and International standards issues and took over BSI's policy team in 2009. David was appointed Director of Standards Policy in 2015.

Experience
• Member of the Council of ISO (since 2017)
• Chair of the CEN/CENELEC Task Force on Africa (since 2018)
• Member of CENELEC’s Policy Working Group (since 2012)
• Member of CEN and CENELEC’s finance committees (since 2010)
• Leader of the UK delegation to ISO General Assemblies, including South Africa 2019
• Chair of the CEN Certification Board (2010-2014)
• Member of the Administrative Board of CEN (2006-2013)
• Represented CEN/CENELEC on the Advisory Board of EA (European Cooperation for Accreditation) (2011-14)
• Convenor of the CEN/CENELEC Working Group Foreign Partnerships
• Chair the annual meetings between CEN/CENELEC and their African counterparts, ARSO and AFSEC (since 2017)

Related activities
• Advisor on technical assistance projects around the world (since 2004) including projects in Rwanda and Tanzania
• Project director for UK Government capacity building projects in Uganda and Zambia (since 2018)
• Articles in journals on standardization in China and USA
• Speaker at conferences around the world on standards strategies, on the economic benefits of standards and on stakeholder engagement, including keynote speeches at the General Assemblies of the African Regional Standards Organization in Rwanda (2014) and Ethiopia (2015)

Graeme Tunbridge - Director of Devices, Medicines and Healthcare products Regulatory Agency (MHRA)

Graeme is interim Director of Devices at the Medicines and Healthcare products Regulatory Agency (MHRA). He has responsibility for Division that ensures 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 has been a civil servant for over 15 years and spent his early career working on healthcare policy. He has previously held Deputy Director roles at the Department of Health and spent 18 months as Private Secretary to the Secretary of State for Health.

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

Eamonn Hoxey - Technical writing, training and consulting - quality & regulatory compliance, sterility assurance, standards development

Eamonn Hoxey, is a technical author, trainer and consultant in a range of 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 for medical devices, pharmaceuticals and consumer products includingVice President of Compliance, Vice President of Market Quality and leading quality implementation for the EU medical devices regulation 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 has participated actively in the development of European and International standards for sterilization and quality management systems, including ISO 9001:2015 and ISO 13485:2016.

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. He received the BSI Wolfe-Barry medal in 2016 for his contribution to standards development.

Suzanne Halliday - Regulatory Director, Head of Medical Devices Notified Body

Suzie is Regulatory Director and Head of Medical Device Notified Body, she has fifteen years of experience within BSI. For eight years Suzie lead the Orthopaedic and Dental team, with responsibilities for aspects of EN ISO 13485 and CE Marking for all global clients. The team was also responsible under numerous Mutual Recognition Agreements for aspects of compliance in Canada, USA, Japan, Taiwan and Australia.

In her current role, she develops strategies, policies and processes for the Medical Devices team to ensure compliance with global regulatory requirements.

Prior to Suzie’s work at BSI she completed a Bachelor Degree and Masters in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford).

Suzie has worked in orthopaedic hospitals in Australia, Canada, Japan, UK and the USA, testing joint replacement implants, spinal and fracture fixation systems. She has also lead clinical investigations on orthopaedic implants.

Helen Forsdyke - Senior Director, Enterprise Regulatory Compliance – EMEA Region, Johnson & Johnson

Helen Forsdyke has been working for Johnson & Johnson for over 20 years and is currently the Senior Director, Enterprise Regulatory Compliance – EMEA Region, working with all the Medical Device, Consumer and Pharmaceutical Segments in the Region to have visibility of End-2-End Quality Compliance. Helen has a degree in Applied Biology, and has a background in industrial microbiology, holding positions of increasing responsibility within J&J, including being the Management Representative for a device manufacturing Quality System. As part of the J&J Enterprise Regulatory Compliance organization, she has executed the Enterprise-wide internal audit program for European Medical Device Regulation readiness and supported Notified Body conformity assessments for many J&J Legal Manufacturers. Helen is currently the J&J representative on the AAMI working groups, specifically participating in QM/WG 01 - Application of quality systems to medical devices and QM/WG 02 - General aspects applicable to medical devices.

Andy Flockhart - Life Science and Medical Device Director, Deloitte

Andy is a Life Science Director within Deloitte’s Consulting practice with a total of 17 years’ global experience at all levels and across many functions of the Health & Life Sciences sector. He spends his time supporting Medical Device Manufacturers, Notified Bodies and health providers with their Regulatory challenges, particularly how to transform themselves and position for growth.

Andy’s most recent projects have included:

Supporting a number of Regulatory Affairs departments in designing their future state model during M&A transactions.
Conducting Regulatory Assessments to evaluate the impact of EU MDR regulations and support the implementation of solutions.
More recently Andy has been heavily involved in helping Medical Device Manufacturers and Notified Bodies evaluate and develop automation strategies to drive business benefit as a direct result of their investments made into MDR compliance.

Paul van Geffen - Senior Manager Regulatory Risk, Deloitte

Paul is a Senior Manager Regulatory Consulting at Deloitte Netherlands with an industry focus on Life Sciences & Health Care. He has 4 years of biomedical research experience and 10 years of industry experience in delivering regulatory compliance and transformation projects covering a wide range of medical devices and technologies including in-depth knowledge of the Medical Device Regulation across the device lifecycle. Paul is (lead) auditor ISO 13485:2016 and he further supports the life sciences industry and regulators with keeping up with the evolving regulatory landscape.

Matt Graf - Director, Corporate Quality Systems, Cook Medical

Matt Graf is Director, Corporate Quality Systems at Cook Medical, headquartered in Bloomington, Indiana. Matt has 28 years’ experience and has held various leadership positions in the medical device industry. He has responsibility for quality system compliance and performance for Cook, which has manufacturing facilities across the United States, Europe, and Australia.

Matt has served on various AAMI, ASTM and ISO standards committees including as a US quality systems expert on ISO TC 210. He has also served on the advisory board for Xavier University’s QARA Institute.

Matt received his Bachelor of Science in Mechanical Engineering from Rose-Hulman Institute of Technology and his Master of Science degree in Quality Management from Eastern Michigan University.

Mark Swanson - President, QRx Partners

Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of Quality and Regulatory Expert Partners, LLC; a group focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI committees) and a RAPS member.

Mark has spent the last several years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485 that was published on March 1, 2016, was the project co-lead for the guidebook on ISO 13485 and has also participated with ISO TC176, WG24 on ISO 9001:2015. He continued to contribute as a the US lead in Working Group 6 on the guidance for post-market surveillance (ISO TR 20416) and in the AAMI group responsible for TIR 102, to formally compare ISO 13485 to the Quality System Regulation. He also participated in the US TAG for risk management (ISO 14971) and the workshop that created IWA 31 (agreement on the application of risk management in standards). This work leads the discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.

Rob Turpin - Head of Sector (Healthcare), BSI

Rob Turpin joined the British Standards Institution (BSI) in 2001 and is currently Head of Sector (Healthcare) for Knowledge Solutions. He leads on the strategic standardization approach for the role that BSI has in supporting trade, regulation, productivity and innovation. His key area of focus include medical devices, software, clinical services and population health. Recent work includes a number of initiatives that support the emergence of artificial intelligence and machine learning algorithms as a medical technology, including collaborations with NHS, regulators, industry and international partners.

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.

Michael Kipping BEng(Hons.), MSc, Ph.D, MTOPRA

Michael works for Innovate UK which is part of UK Research & Innovation. He is responsible for the management of a Government grant funding program called the Biomedical Catalyst that supports UK SMEs developing innovative health & life science products.

To date, the program has provided £210 million in grant funding to UK life science SMEs to support the development of 501 innovative projects/products at different stages of development that are unlikely to have proceeded without this grant funding.

He also provides specialist expertise to Innovate UK for medical devices and diagnostics products. This involves working closely with other bodies such as NIHR, MHRA, DoH, OLS, BEIS, ABHI, BIA, Bionow etc. to find opportunities to accelerate the development and commercialisation of products developed by UK SMEs.

Previously, Michael was a Group Manager at Medicines & Healthcare Products Regulatory Agency (MHRA) and spent 10 years in the medical device industry working for Guidant, Boston Scientific and BIOTRONIK where he was Country Director UK & Eire.

Michael is a member of EPSRC Healthcare Technology Strategic Advisory Board, STFC HealthTech Cluster, EPSRC funded 2D Health programme at University of Manchester, Grow MedTech Leeds City Region, NIHR Surgical MIC (Leeds) and TOPRA MedTech SPIN.

Joe Lewelling - Senior Advisor on Content & Strategy, AAMI

Joe Lewelling is the Senior Advisor on Content and Strategy at AAMI. He plans, organizes, and conducts industry conferences and summits on safety, standards, and medical technology regulation. He is also responsible for developing and implementing association strategies vis-à-vis emerging medical technologies and new standards initiatives. Joe has been with AAMI for over 30 years and administered the AAMI sterilization standards program for more than 25 years. In recent years he has led AAMI’s new standards work on health IT, artificial intelligence and medical device interoperability. He has served as the Committee Manager for several ISO Technical Committees and is currently filling that role for ISO/TC 210, Quality management and corresponding general aspects for medical devices. Joe is a member of the ANSI Executive Standards Council and holds master’s degrees in Physical Anthropology from the University of Tennessee and in International Business Regulation from George Mason University.

Tony Wilkes - Consultant, HAS (Harmonised Standards)

Tony is currently an independent consultant on medical devices, standards and statistics, in particular as a HAS (Harmonised Standards) Consultant contracted by Ernst and Young on behalf of the European Commission to assess draft standards developed by European Standards Committees to support European legislation.

From 1988 to 2013, he worked in the Department of Anaesthetics, Intensive Care and Pain Medicine in Cardiff University (and prior to that, before merger, in the University of Wales College of Medicine). He evaluated medical devices used in anaesthesia and respiratory care from 1988 to 2004 for the UK Government. He started participating in BSI and ISO technical committees developing standards for such equipment in 1988.

From 2004 he was involved with and then led courses on research and statistics and, later, as Acting Research Director, he was involved in leading many research projects in the Department of Anaesthetics. He has published in many leading anaesthetic journals and chapters in books and obtained a PhD on breathing system filters in 2005.

He was joint lead for two Buyers’ Guides for the Centre for Evidence-based Purchasing, part of the NHS Purchasing and Supply Agency in 2008 and 2009.

He started working as a consultant on medical devices to CEN and CENELEC in 2009.

Professional and other relevant activities

Scientific Officer of the Difficult Airway Society Committee (2016 to 2018)

Section editor for the Oxford Textbook of Anaesthesia (2017)

Joint lead on a project for AAMI (Association for the Advancement of Medical Instrumentation) on the ISO 80369-6 small-bore connector for use with ‘Neuraxial’ medical devices’ (2014)

Training Officer on the Anaesthetic Research Society Council (2007 to 2010)

Involved in Working Parties of the Association of Anaesthetists of Great Britain and Ireland developing guidance documents

Awards

Honorary title of Professor of Anaesthesia and Airway Management 2015, Difficult Airway Society (2014)

Pask Certificate of Honour, Association of Anaesthetists of Great Britain and Ireland ‘in recognition of distinguished services in the specialty of Anaesthesia’ (2007)

Nele Zgavc - International Lead Programme Manager (Healthcare), BSI

Nele Zgavc is the secretary to the CEN/CENELEC Advisory Board on Healthcare Standards (ABHS) and the international committee manager for the committee on ageing societies. Since 2015, she has been working in standards development for the British Standards Institution. Over the years her standards portfolio has been mainly focused on the healthcare, risk management and medical devices.

Currently, ABHS is supporting CEN/CENELEC with the ongoing discussions and developments regarding the standardization request to support the MDR and IVDR.

Richard Bancroft - Science and Technical Director, STERIS

Richard has over 33 years’ experience in sterilization and medical devices, and is a IHEEM-Registered Authorising Engineer (Decontamination) (AE(D)), has a BSc (Hons) Degree in Applied Chemistry and is a Fellow of the Royal Society of Biology (FRSB) and has been granted 5 patents in USA and other countries.

He is Chairman of ISO/TC 198 and has actively driven international standards for over 25 years. He is the convenor of ISO/TC 198 WG 6, CEN/TC 102 WG 7 and AAMI/ST WG06. He was awarded AAMI’s 2014 Standards Developer Award.

Lena Cordie-Bancroft - President, Qualitas Professional Services

Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Service, where she works with medical device, dental and IVD companies to implement ISO 13485 and FDA QS Regulation compliant quality management systems, supporting processes to comply with FDA and international regulatory requirements related to quality systems, risk management, and global regulatory compliance related to labelling and Unique Device Identification (UDI) requirements. She is a member of AAMI Sterilization Standards, ISO/TC 198 and ISO/TC 210 work groups. She is an active member of RAPS, and is chairperson for the Twin Cities Chapter, a member of the RAPS European Committee (REC) and a leader of the UK Local Networking Group.