BSI/AAMI International Standards and Regulations Conference

Recorded: 29 June 2021 (13:00 - 17:00 UK time)

Recorded: 30 June 2021 (13:00 - 17:10 UK time)

What’s this conference about?

This is a wide-ranging free online event during which invited healthcare subject experts, regulators, medical device manufacturers and standards-makers share their knowledge, insights and perspectives on the key issues affecting the medical device sector now and in the next couple of years. This year’s conference continues our emphasis on regulatory compliance and patient safety and also reflects on COVID-19’s impact on the future of healthcare technology.

Who is this webinar for?

Healthcare and medical device manufacturers, specifically:

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

What will you gain?

• Insights into the digital transformation of healthcare in the wake of COVID-19
• Advice on how to prepare for the EU IVD medical devices regulations
• Authoritative information on the introduction of the UKCA mark in May 2023
• An analysis of QMS in safety-critical industries in the light of the Ventilator Challenge
• Perspectives on the impact that sustainability will have on healthcare delivery and technology
• First sight of the standards that will support post-Brexit regulatory compliance
• An update on the issues affecting regulation and compliance in the US

Please click here to view the agenda.

Develop your personal knowledge and understanding of the key topics currently shaping this dynamic market.

Our speakers

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)

Amanda Benedict, MA, AStd, is Vice President, Standards at the Association for the Advancement of Medical Instrumentation (AAMI), a role assumed in 2020 after joining AAMI as a Standards Director in 2015. In addition to overseeing the strategic and operational functions of AAMI’s expansive and dynamic Standards program and portfolio, her work includes managing the national and international work program for the AAMI Sterilization standards portfolio, which includes serving as the Secretary and U.S. TAG Administrator for ISO/TC 198 on sterilization of health care products. Ms. Benedict has authored and reviewed articles for AAMI publications and designed, developed, and/or delivered educational sessions at conferences and workshops including AAMI, International Association of Healthcare Central Service Material Management (IAHCSMM), Association for Professionals in Infection Control and Epidemiology (APIC) and the American National Standards Institute (ANSI).  

Earlier in her career, she managed the Society for Human Resources Management (SHRM) program to develop national and global standards for human resource management and led research on human resource management and workplace practices, professional competencies, healthcare, and education and employment trajectories.

Ms. Benedict previously served two terms on the Board of Directors of SES – the Society for Standards Professionals and in August 2020 was honored with the SES/CSA Lorne K. Wagner Memorial Award in recognition of outstanding contribution to SES.

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.  In addition, Ms. Benedict holds the Associate Standards Professional Certification (AStd), reflecting expert knowledge and application of standards and standardization processes.

Professor Shafi Ahmed is a multi award winning cancer surgeon working at The Royal London Hospital. He is a member of the NHS assembly advising the government on the NHS Long Term Plan and was awarded the Future NHS Award by members of Parliament in 2018. He was also the Asian Star in UK Tech in 2018. He won the Silver Scalpel as best national trainer in surgery in 2015 and has been given the accolade of the worlds most watched surgeon as has streamed live operations using Google Glass, Virtual Reality, social media and on national television on Operation Live which was shortlisted for a BAFTA award in 2019.

He was the Associate Dean of Bart’s Medical School and an elected member of council of the Royal College of Surgeons of England where he led the international and global health programme. He has been recently appointed as an advisor to the Abu Dhabi government for digital transformation of health and innovation. He is the Vodafone Connected Health Ambassador 2020.

He is faculty at Imperial College, Barts Medical School, Queen Mary University, Bradford University, Harvard Medical School and Singularity University where he teaches on innovation and digital transformation. He has set up surgical education programmes in over 20 countries including conflict zones. He is a Visiting Professor at Imperial College London, Honorary professor at Bradford University and The Spinoza Visiting Professor at the University of Amsterdam.

He is the Associate Editor for technology and innovation at the Annals of Royal College of Surgeons and a member of the Editorial Strategic Advisory Board of BMJ Innovations.

He cofounded Medical Realities a VR education company and sits on the board and advises major medtech and pharma companies. He is an advisor for Imera, an AI musculoskeletal radiology diagnostic company.

He chairs the Webit Health summit in Spain and co founded the GIANT health summit in London. He is one of the top 20 global influencers in digital health and innovation and is a HIMSS Future50 clinical leader 2019.

He is an 3x TEDx and international speaker having delivered over 250 keynotes in over 30 countries on innovation, the future of healthcare and digital transformation. His work has been featured in over 400 newspapers, tech journals and mainstream TV news channels including Sky, BBC, ITV BBC World, CNN, ABC, Al Jazeera,.RT, China TV, CNBC, Forbes, Bloomberg, Time, Wired, Guardian, The Times.

Erica has over 20 years experience in the In Vitro Diagnostic (IVD) medical device and pharmaceutical industries, within Regulatory Affairs and Quality Assurance.  Following a BSc (Hons), PhD (Neurophysiology) and Post-doctoral research, Erica’s industrial experience started at GlaxoSmithKline in the regulation of pharmaceuticals. Further she worked in the arena of clinical trials for medicinal products for Quintiles. Erica then moved into the field of IVD medical devices when she became the Regulatory Affairs Manager for Axis-Shield Diagnostics (Alere Toxicology; now Abbott). She then went into performing independent consultancy work and continued working within the IVD and medical device field, as a continued member of British IVD Association, prior to joining BSI.

Erica joined BSI at the beginning of 2014 as a Technical Specialist/Scheme Manager in the IVD medical devices team. She took the position of Global Head of the IVD Medical Device Team in June 2016, to lead the IVD Technical team through transition of the Notified Body (NB) to the new EU IVD Regulation; leading to the successful designations of BSI UK and BSI NL NBs to the IVDR. She is leading the IVD Technical team for operational delivery of IVDR Technical Documentation assessments and expanding the team to meet the increased resource demands under the IVDR. Erica represents the NB on Team NB/NB-Med for IVDs.

Philippe joined Abbott in 1994. He is currently Senior Director Regulatory Strategy and Advocacy

He represents European Industry in various European Commission expert groups and actively participates as trainer in programs organized by Regulatory Authorities around the world. Since 2015 he is and Industry advisor to the Asian Harmonization Working Party Technical Committee.

He is Chair or co-chair of the Post Market Surveillance, the Notified Body, the International Regulatory and the clinical Working Groups of the European medical device manufacturers’ trade association Medtech Europe.

Philippe is a member of the European Advisory Committee and of the board nominating committee of the Regulatory Affairs Professional Society (RAPS). Philippe  received the “Global Leadership Award” from RAPS in 2010, has been elected “RAPS Fellow” in 2012.

Philippe is also the proud recipient of an FDA CDRH Director’s “Special Citation” for his work at Global Harmonization Task Force.

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

Work for Meggitt Plc, Group Quality with responsibility for Group Quality globally, ensuring policy and strategy is flown down and implemented at all sites. Influencing site Quality teams in driving Group initiatives and meeting KPI’s.

Supporting sites across all sectors; aviation, automotive, industrial and oil and gas in maintaining regulatory and certification body approvals and supporting customers in zero defect initiatives.

Teresa Perry is the Global Assessment Delivery Director at BSI, Notified Body. She has strategic and operational responsibility for the wellbeing of all medical device QMS auditors and for the delivery of compliant medical device audits in line with customer and regulator expectations. Previously the Quality and Accreditation manager, she oversaw and supported the ISO13485, MDSAP and CE delivery and certification processes, implemented new QMS schemes, standards transitions and regulatory guidance documents, managed certificate issue and auditor qualification processes and process improvement.  She has worked at BSI for 19 years in a number of other roles such as a certification lead, scheme manager for ophthalmic products and a QMS auditor. Prior to BSI, Teresa worked in industry in the field of disposable contact lenses in both production management and quality management systems and holds a bachelors degree and masters degree in Chemistry.

Jayanth is the Head of the UK Approved Body for Medical Devices at BSI and a Senior Regulatory Lead. He is responsible for the regulatory oversight of Medical Devices Approved Body and wider BSI strategy, policies, procedures and documentation to meet the various legislative and designation requirements. He has held other roles such as 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 Biomedical Engineering from the University of Leeds.

Vishal holds a Masters in Medical Engineering from Queen Mary University of London and has over 8 years experience within industry, third party testing and at BSI. For the past 5 years he has been at BSI working first as Scheme Manager/Technical Specialist in the Active Device team reviewing technical files against the MDD and MDR, then as a Technical Team Manager within the Active Devices Team. His most current role in BSI is working as a Regulatory Lead along with the Head of the Notified Body and Head of the UK Approved Body.

Mary Ryan is Director of Innovation, Technology and Regulatory Affairs at Penlon Ltd, responsible for delivering the strategic, quality, and technical requirements in the development of medical devices for global markets. With almost 30 years in quality assurance, Mary champions efforts to bring a more modern technology outlook to Penlon’s product vision and is driving initiatives in the area of creating and levering new technology solutions and clinical partnerships. Over the years, Mary has made noteworthy contribution in influencing positive changes in global medical device regulations, including UK policy.  Mary is an active participant of the ABHI Technical Policy group and more recently, Mary was a key leader in the UK NHS Ventilator Challenge.

Our speakers

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.

Peter Schroeer has served since 2018 as the Europe Middle East Africa and Canada as the Regional Vice President for Regulatory Affairs at Johnson & Johnson.

Prior to joining Johnson & Johnson, Peter began his career in the chemical industry, where he supported various start-ups of new innovations and manufacturing sides. In the Medical Devices industry, he set up manufacturing and servicing structures for active and passive medical devices, and lead Quality System as well as Product certification programs according to international standards, national and EU Medical Device regulations. He is a certified EOQ (European Organization for Quality) Quality Manager and auditor.

Since joining Johnson & Johnson in 1996, Peter served as the authorized representative for various Business Units, lead EMEA Quality and Regulatory teams and established a sector wide regional regulatory affairs infrastructure. As the Senior Director Policy Innovation, he was responsible for ensuring global regulatory policies were appropriately interpreted, effectively communicated, and efficiently implemented in the Johnson & Johnson Medical Devices companies. Prior his current role he lead the EMEA Medical, Clinical and RA team.

Peter holds an Engineering Diploma from the University of Münster – Steinfurt and serves as an active member of MedTech Europe where he is the Vice Chair of the Regulatory Affairs Council.

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.

Frank is an NHS anaesthetic Consultant and Climate Change Lead for West Yorkshire and Harrogate Healthcare Partnership. 

Since working for the British Antarctic Survey for two years, he has been trying to reduce the environmental impacts of his home and work. He sits on the environment committee of the Association of Anaesthetists, he is a Trustee at Sustrans, has an MSc in Strategic Leadership towards Sustainability and is a (very) amateur beekeeper.

Dr Duncan McPherson is Clinical Director of Medical Devices at Medicines and Healthcare products Regulatory Agency, UK. He is a Fellow of the Royal College of Anaesthetists. He is an honorary consultant anaesthetist at Queen Alexandra Hospital, Portsmouth where he was head of anaesthesia patient safety and clinical governance for critical care, anaesthesia and operating theatres. He worked for the National Patient Safety Agency as a clinical adviser and has undertaken research on epidemiological methods for describing avoidable harm and on patient safety incident reporting systems. He contributed to the WHO patient safety curriculum guide for medical schools.

Currently he is leading the Devices Clinical Team at MHRA. Devices Division at MHRA is the national competent authority for regulating medical devices in the UK. They work to generate continuous improvement in the safety, effectiveness and usability of medical devices.

Rachel Frost has been the Environmental, Health and Safety Manager for just under 10 years at Intersurgical, a Manufacturer of Medical Devices for respiratory support. One of her main responsiblities within the company is managing the Environmental Management System, certified to ISO 14001:2015, with the aim to minimise the environmental impacts of the company’s products, activites and services. Rachel is qualified with a BSc in Environmental Protection and an MSc in Environmental Management, with previous work experience within waste management and volunteering for wildlife conservation charities.

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)

Richard Collin has been BSI’s Head of European and National Policy since 2016. He leads BSI’s standards work on trade and regulatory policy, which covers the role of standards supporting UK regulations, the role of international standards in UK trade policy and standards issues following the UK’s exit from the EU such as CEN and CENELEC membership. He also manages consumer policy, including BSI’s Consumer and Public Interest Network, which enables the representation of consumers in BSI’s standards committees.

Richard has over 30 years’ experience in quality infrastructure. After qualifying as a Trading Standards Officer, he worked for UK local authorities for 9 years in the fields of market surveillance, consumer protection and legal metrology. He was then resident advisor to the Hungarian government on behalf of the UK Department of Trade and Industry (now Department for Business, Energy and Industrial Strategy) for two twinning projects on market surveillance from 2000 to 2003.

Richard subsequently spent 6 years working in the European Commission, Directorate-General for Enterprise and Industry (now DG GROW), standardization unit, developing standards policy and facilitating all Commission standardization requests (‘mandates’) to the European Standards Organizations.

He has been working in BSI Since 2010. Initially he was Principal International Development Manager in BSI’s International Projects Department. Here he acquired and managed a wide range of projects on quality infrastructure around the world, including in Ukraine, the ASEAN region, Barbados, Sierra Leone and Croatia.

In February 2012, he moved to BSI’s Standards Policy team as National and European Policy Manager. In this role, Richard worked on UK government relations and was responsible for BSI’s standards policy in relation to the EU, including authoring CEN and CENELEC Guide 30, European Guide on Standards and Regulation.

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.

Michelle Kelly is Biological Safety Manager for MHRA devices. She has worked for the agency since 2008 and current responsibilities include principal lead on all clinical trial applications for biological safety, provide expert biological safety advice and direction to the regulatory and safety and surveillance teams on compliance, vigilance and Notified Body matters. She also works with key stakeholders towards the development of international standards to help innovation to the UK market. She is currently the chair of CH/194, a committee responsible for the UK input to ISO/TC 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices. She has a BSc in Biomedical and Advanced Materials from University of Limerick in Ireland, an MSc in Applied Toxicology from University of Surrey and she is a European Registered Toxicologist.

Pat Baird works at Philips as the Head of Global Software Standards. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and  developers, and developing standards, whitepapers, and training to meet those needs. His current passion is related to artificial intelligence in healthcare; he is co-chair of a CTA committee on healthcare AI, co-chair of a WHO AI quality management committee, is active on ISO/IEC SC42 AI standard committees, is active in trade associations related to AI, etc. Past roles have included software developer, engineering manager, project manager, lead engineer, and most recently he was the Director of Risk Management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented over 50 papers regarding product development. He has an MBA from Marquette and a Masters in Healthcare Quality and Patient Safety from Northwestern University.

Scott A. Colburn, CAPT, Commissioned Corps of the U.S. Public Health Service, is the Director of the Standards and Conformity Assessment Program at the Food and Drug Administration’s Center for Devices and Radiological Health. In this role, Captain Colburn is responsible for the Center’s standards recognition and related development activities in 600+ national and international consensus standards committees. In addition, Scott oversees the program’s new Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and the Center’s efforts to optimize standards for regulatory use within the International Medical Device Regulators Forum.

Captain Colburn has served in numerous roles in the area of premarket review and voluntary consensus standards development and implementation for medical devices. He is a member of numerous national and international standards organizations and serves on several policy and leadership committees.

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