Dr Donal B O’Connor is the Clinical Manager for Medical Devices at the HPRA, overseeing the HPRA representation at the Clinical Investigation and Evaluation Working Group of the European Commission and contributing to various task forces and research consortia related to clinical investigations and clinical evidence methodologies for medical devices. Donal is also co-chair of the European Commission MDCG task force on orphan devices, which authored the European clinical evaluation guidance for orphan medical devices. Donal regularly lectures and presents on clinical aspects of medical device regulation.

Prior to this, Donal worked in clinical trial assessment and also regulated medicines and vaccines with the HPRA and EMA.
Before working in regulation, he trained in General Surgery. Donal is a fellow of the European Board of Surgery, an adjunct lecturer at Trinity College Dublin, and has co-authored over 60 publications.

Carlo Maria Petrini serves as the Director of Research at the Istituto Superiore di Sanità (ISS – Italian National Institute of Health) and the Director of the Bioethics Unit at ISS. He holds several key positions, including Chair of the National Ethics Committee for clinical trials of public research bodies (EPR) and other public bodies at the national level (at the ISS). Additionally, he chairs the National Centre for the Coordination of Ethics Committees and is a member of the National Bioethics Committee under the Presidency of the Council of Ministers. He is also a Corresponding Member of the Pontifical Academy for Life.

Furthermore, Carlo Maria Petrini is a member of the National Advisory Technical Group on Vaccinations (NITAG) of the Ministry of Health and participates in the Working Group on clinical research with drugs and medical devices for human use (Ministry of Health). He contributes to the Technical Table for in-depth analysis of the treatment of gender dysphoria (Ministry of Health and Ministry for the Family, Natality and Equal Opportunities). Lastly, he serves as the Deputy Chair of the Clinical Ethics Committee of the Bambino Gesù Children’s Hospital.

Dr Gry Dahle has been a specialist in Cardiothoracic surgery since 2010 and works as a consultant surgeon at Oslo University Hospital. She has a special interest in mini-invasive surgery and catheter treatment, and in addition, device and mechanical treatment of heart failure. She did her thesis on “The Introduction of Transcatheter Aortic Valve Implantation (TAVI) Clinical, patient experience, economical and occupational hazard issues”.

She is engaged in innovation and implementing new methods of education. She is also the Associate Editor of Innovations and ICVTS. She is chair of the National Ethical Committee, REK KULMU B and in the reference group for National New Methods. She is Vice Precedent (incoming president 2026) of ISMICS (International Society of Mini-invasive Cardiac Surgery) and lead of level 2 Exam EBCTS (European Board of Cardiothoracic Surgery). She is on the program committee of ESC (European Society of Cardiology), EACTS (European Association of Cardiac Surgery) and CSI Frankfurt/D-HF CSI.

Professor Volkmar Falk is the Medical Director of the Department of Cardiothoracic and Vascular Surgery of the Deutsches Herzzentrum der Charite (DHZC) and Chairman of the DhZC Board. He is also a Professor of Transnational Cardiovascular Technologies at the ETH in Zurich.

Rob Nelissen is professor and chairman of the Department of Orthopaedics, Rehabilitation, and Physiotherapy at Leiden University Medical Center (LUMC). Title doctorate thesis (1995): ‘Fundamental aspects of the clinical evaluation of total joint prosthesis’. After his orthopaedic training (Leiden), he finished a Total Joint Fellowship in the USA (1993). 2005 Professor Experimental Orthopaedics. 2006 Chairman and professor Orthopaedics LUMC. 2016 Medical Delta Professor at Delft University of Technology. He was (vice)president of the Netherlands Orthopaedic Association (NOV) (2014 – 2018). He is the co-founder (2007) and former chairman of the Dutch Arthroplasty Register (LROI), which is the third largest implant registry worldwide (> 1.1 million implants, completeness 99%). The LROI is a quality and traceability Register of implant surgery and patient outcomes. Currently he is chairing the registration council of LROI. He is vice-President of EFORT and co-chairman / co-founder of N.O.R.E. (Network Orthopaedic Registries of Europe).

Since 2019, he has been an observer of the CIE workgroup of MDCG (Medical Device Coordination Group) DG SANTE European Commission. Chairman Expert Panel Orthopaedics Trauma Rehabilitation Rheumatology under the MDR (EU commission, EMA). His research relates to “optimising clinical outcome” and “prediction modelling of outcome”. The latter relates both to fundamental research and healthcare evaluation research. He published about 500 peer-reviewed articles, with a focus on healthcare evaluation and prognostic modelling and optimizing outcomes in arthroplasty patients. He successfully supervised over 65 PhD students.

Peter McCulloch is Professor of Surgical Science & Practice at Oxford University and Chair of the IDEAL Collaboration.  He is also co-editor and chief of the journal BMJ Surgery, Interventions and Technology.  His research interests are in (a) improving the methodology for evaluating surgery, complex therapeutic procedures and technology, and digital health technology.  IDEAL promotes integrated evaluation pathways in which interventions are subjected to studies appropriate to the needs of each stage in their life cycle, as well as maximum feasible transparency and rigour. Recent publications include the DECIDE-AI guidelines for early clinical evaluation of healthcare AI and the Robotics Colloquium guidelines for holistic evaluation of surgical robots (b) Using Human Factors approaches to improve the effectiveness and safety of surgical pathways.  The ongoing RESPOND trial aims to reduce the mortality from surgical complications using a four-stranded bundle of Human Factors interventions  (c) Developing solutions for risks to human health posed by climate change.

Current work includes the evaluation of Anticipatory Action plans for lethal heat events.  He was a member of the Horizon 2020 CORE-MD consortium, where the IDEAL group demonstrated that the current regulations around the role of Notified Bodies in the CE marking process effectively prevented any methodological innovation from improving the clinical evaluation of medical devices.

Gearóid O’Connor is a Medical Officer for Medical Devices at the HPRA. Along with assessing clinical investigation and performance study applications at a national level, he represents the HPRA at the Clinical Investigation and Evaluation and Performance Studies and Evaluation working group at an EU level. He has led and continues to lead work to improve the quality of clinical investigations and performance studies in Europe.

Françoise Schlemmer has been the director of Team-NB since the association’s founding in 2001. She holds a master’s degree in medically oriented biochemistry and a diploma in economics and management. She has extensive experience at all levels of the medical device sector, including manufacturers, consultants, and notified bodies. She also participates in the Medical Devices Coordination Group (MDCG), working groups, conferences, and panels.

Team-NB is an association that brings together 40 notified bodies in the medical device sector and members in the designation process. The designated members issue more than 80% of certificates worldwide. Team-NB actively seeks to encourage continuous product improvement and development, allowing patients increased access to safe yet innovative devices. With this objective, Team-NB is involved in the implementation of the two new regulations as well as strategies for greater efficiency. Team NB also aims to develop the harmonization of best practices among our members.

Patrick Myers is a consultant cardiac surgeon in Switzerland. After finishing medical school in Geneva, Switzerland, he completed a cardiovascular surgery residency at the Geneva University Hospitals, then served as a senior fellow in adult cardiac surgery at Brigham & Women’s Hospital (Larry Cohn) and Harvard Medical School and then as a fellow in cardiac surgery at Boston Children’s Hospital (Pedro del Nido). Since 2017, he has focused on adult cardiac surgery in private practice in Geneva and serves as a consultant cardiac surgeon at CHUV Lausanne. He served as a member of the board and secretary of the European Board for Cardio-Thoracic Surgery, then as chair of the Acquired Cardiac Diseases Domain of EACTS, and now as Secretary General of EACTS. He also had the privilege of serving as president of CTSNet, the joint venture between the three main surgical associations (AATS, EACTS and STS). His clinical practice and research interests focus on arterial coronary artery bypass grafting, evolving transcatheter techniques to treat structural heart disease, and critical appraisal of clinical trials and their discussions on social media.

Rachel Mead holds an Honours degree in Electronics and Electrical Engineering from the University of Glasgow and is a member of the Institution of Engineering and Technology. Rachel began her career twenty years ago as a research scientist in industry. Since then, she has held various research and development positions in medical device companies and has experience with clinical investigations of medical devices.

After joining BSI as a Technical Specialist and Scheme Manager in 2018, Rachel currently holds the position of Clinical Regulatory Lead. She focuses particularly on the clinical evaluation of medical devices.

Dr Amie Smirthwaite has a PhD in biomedical engineering and undergraduate degrees in biomedical engineering and mathematics. She has 30 years of experience in medical devices, spanning new product development, regulation and quality, with a particular focus on clinical evidence. She is SVP of Scientific Affairs at RQM+, a dedicated medtech CRO. Prior to joining RQM+, Amie was Global Head of Clinical Compliance at BSI. She established BSI’s clinical compliance team and led clinical aspects of BSI’s successful designation under EU MDD, MDR and IVDR. Amie has been involved in numerous expert working groups within the EU addressing the interpretation and implementation of clinical evidence and postmarket surveillance and has contributed to many MDCG and MedDev guidance documents

Amie is currently a member of ISO technical committees CH/194 (Biological and clinical evaluation of medical devices), CH/150 (Implants for surgery), and CH/210/4 Risk analysis for medical devices and is a core member of the committee drafting ISO 18969, clinical evaluation for medical devices. She is currently on the Advisory Board of NORE (Network of Orthopaedic Registries of Europe) and has previously been involved with initiatives such as CORE-MD (Coordinating Research and Evidence for Medical Devices, European Union Horizon 2020 project), ODEP and the European Society of Cardiology’s mHealth initiative. Amie has developed extensive training materials in clinical evaluation, technical file construction, biological safety, risk management and ISO 13485. and has trained hundreds of manufacturers and notified body reviewers of these requirements.

Claudia Wild was director of the Austrian Institute for Health Technology Assessment (AIHTA, former LBI-HTA 2006 – 2020) from 2006 to (Feb) 2025. During these years the AIHTA was coordinating the European collaboration (EUnetHTA) on assessments of medical devices.  Since March 2025 Claudia has retired from her job, but is still active in diverse Advisory Boards.

With over 35 years of experience within the medical device and in-vitro diagnostic industry, Ms. Danielle Giroud is founder of MD-Clinicals (https://www.md-clinicals.com), a purely medical device and in-vitro diagnostic-focused CRO with offices in Switzerland, Frankfurt, and Beijing.

Ms. Giroud is regarded as an internationally recognized clinical research and regulatory expert, having shared her extensive knowledge and experience with hundreds of multi-national companies, organizations, and start-ups from around the globe to help bring their products to market quickly and efficiently.

She is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (https://www.wmdo.org) and is a recognised subject matter expert providing extensive training around the world.

Since 1998, she has been extensively involved in ISO work and became in 2008 the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and 18969 on clinical evaluation.

From her position as a convenor of the TC 194 WG 4 she is a firm believer in regulatory convergence and established the liaison with the EU Commission – Clinical Investigation and Evaluation (CIE) task force and other regulatory authorities throughout the world.

Board-certified Neurosurgeon and Global Expertise Manager at Tuv Sud.

With 16 years of clinical experience in hospital setting in a Neurosurgery Department, became a full-time Clinical Reviewer with Tuv Sud in 2021 and Global Expertise Manager in 2023.

Vast experience in clinical assessment of high-risk medical devices, especially in neuromodulation area. Special interest in BCI technology having recently joined the iBCI-CC.

Condition: Spinal Muscular Atrophy (since birth)

Individual background: Working in Digital HealthTech for a few years. Very passionate about improving Access and Quality of Healthcare. Since climbing and jogging is not my biggest passion I enjoy leisure time with reading a good book or cultural activities.

Experience in patient advocacy: Involved in various SMA, NMD & RD-related activities. Especially in DGM (German Association for Muscles Dieses), SMA Europe, and the Digital and Data Advisory Group of EURORDIS, while also being an EUPATI Alumni. Active in all of these activities between 1-7 years.

Condition: Multiple sclerosis, diagnosed in 2016

Individual background: Cornelia is a mechanical engineer working in software quality.

Experience in patient advocacy: Cornelia started being active in NGOs in 2019, initially at the national level and between 2020 – 2023, went to STYPA (Skills Training for Young Patient Advocates) from EPF (European Patients’ Forum), where different advocacy subjects were tackled. In 2021, she became a member of EPF’s Youth Group, where she worked on two projects: “Sexual Health and Wellbeing” and “Youth Involvement in Patient Organisations”. I am also a part of the EMSP (European Multiple Sclerosis Platform) Young People’s Network, and together with them, she participated in EYE (European Youth Event) in 2023 with a project called ACT (Activist Cut Through) with the purpose of highlighting matters that are important for us to be tackled by the EU in 2024.

Condition: At the age of 34, she suffered a Cerebral Venous Thrombosis and has since been undergoing rehabilitation, learning to be independent with half of her body paralyzed. She initially thought strokes only affected older people and couldn’t imagine how difficult it would be to sit, stand up, walk, or even eat after a severe brain injury. Stroke is the main cause of death and morbidity in her country, and she feels that people aren’t fully aware of its burden.

Individual background: Happily married, she is a full-time mom and had the ‘privilege’ of giving birth to her third child two years after her stroke, which she considers a blessing.

Experience in patient advocacy: She no longer works as a journalist. Instead, she has become a patient advocate, a board member of the first Portuguese stroke survivors organization, and the national coordinator of the Stroke Action Plan for Europe.

Condition: aortic stenosis and regurgitation, aortic valve replacement in 2018, since then living with a mechanical aortic valve including anticoagulation self-monitoring

Individual Background: University Diploma in Business Sinology: Chinese Language and Writing, Intercultural Communication, Business Administration and International Economics

Interests and motivation: The saying “Nothing about us without us” motivates Jens in his daily work as a heart valve patient and representative of a patient organisation in the cardiovascular field. In his opinion, the area of “Patient Centrificy” is still in its infancy at the moment. Making a contribution here appeals to him and motivates him.

Experience in patient advocacy:

• • Preparation of project applications for clinical studies in cooperation with several German university hospitals, e.g. cardiac surgery at the University Hospital Bonn, cardiac surgery at the University Hospital Augsburg or Charité Berlin for funding announcements of the Federal Ministry of Education and Research
  • Member of national and international advisory committees and multi-stakeholder working groups for the drafting of documents such as
    • Paving the way: a roadmap to the successful implementation of shared decision-making in heart valve disease
    • Shared  decision-making for people with heart valve disease
    • Heart Valve Disease – working together to create a better patient journey
    • Heart valve diseases in Germany. Faster to effective treatment
  • Speaker at various national and international events, e.g. in front of health politicians in the German Bundestag, in front of doctors and scientists during the Heart Valve Summit 2023 in Malaga, Spain or during the Unite Summit 2023 in a Lived Experience Panel Discussion in Barcelona, Spain
  • Design and implementation of surveys, including “Heart Valve Diseases. A survey of patients and doctors to assess the current situation in Germany and Austria“
  • Planning and realisation of awareness campaigns and information events
  • Creation of patient and doctor videos as an educational tool and encouragement for patients
  • Non-medical counselling of patients

Condition: Type 1 Diabetes for 32 years

Individual Background: Specialized in patient rights law and diabetes education, Lucía’s passion lies in global health advocacy. Actively engaged with the international community, she participates in various global campaigns and organizations such as the International Diabetes Federation (IDF), the NCD Alliance, and as an ISPAD advocate.

Experience in patient advocacy:

Benefiting from advocacy training by the NCD Alliance, Lucía has distributed diabetes information and empowered individuals living with this condition from legal, emotional, and educational perspectives.

Currently, she serves as a Global Advisor for the NCD Alliance, playing a pivotal role in advancing global efforts to address non-communicable diseases (NCDs). Additionally, she is a member of the Patient Advisory Committee for the European project Invest4Health.

Collaborating with the World Health Organization (WHO), Lucía has co-created and moderated events on diabetes, including the inaugural symposium on meaningful engagement of people living with NCDs, mental health, and neurological conditions. Beyond advocacy, she staunchly supports universal health coverage and meaningful engagement of people living with NCDs. Certified as a patient expert, Lucía offers specialized insights and guidance.

She is also part of the Diabetes Center Berne Lived Experience Panel and an international activist with T1International, furthering her commitment to advancing diabetes advocacy globally. Additionally, Lucía is a member of the Patient Advisory Network of Medtronic EMEA, contributing to improving patient care and advocacy efforts in the region. Furthermore, she serves as an expert for the European project ASSESS DHT, providing invaluable insights to enhance its objectives. As a voice for global diabetes initiatives, she actively promotes awareness and engagement worldwide, reflecting her dedication to global health advocacy through diverse initiatives.

Condition: Cardio Vascular Disease (CVD) Patient for 17 years as a result of a heart attack in July 2007.

Medical history: Initial 11 years with dilated heart disease (years 2007-2018) with ICD (Implantable Cardioverter Defibrillator) implanted; following five years with LAD (Left Ventricular Assist Device) implanted (years 2018-2023) as a bridge for a heart transplant; Heart Transplanted on July 2023.

Individual background: Italian Navy Pilot Officer who retired in Jan 2017. Interested in Jazz music, currently playing Guitar in a Jazz Orchestra for fun. Massimo likes to travel to see new places and cultures.

Member of AISC (Ass. Italiana Scompensati Cardiaci), AIDO (Ass. Italiana x Donazioni Organi) and Vice President of ACTI (Ass. Cardio Trapiantati Italiana) sez. Roma.

Experience in patient advocacy: Various experiences in National and Joint International Military Projects.

Currently, as a volunteer, he is a directive member of the AISC, AIDO, and ACTI Boards, actively promoting the Association’s purposes (especially the importance of organ donations) and responsible for any association’s event/conference planning and organization.

With patient focus and their support/benefit in mind, he constantly engages people (mainly associated members) lith heart disease to distribute information and share experiences, provide education, and dispense advice on how best to live with CVD.

Condition: Cardiovascular (40 years), Respiratory (12 years)

Individual background: Experienced Patient & Public Involvement research partner, Phil works mainly around cardiovascular and respiratory conditions, actively promoting patient/public involvement of ‘lived experience’ in the research cycle.

He has collaborated on numerous projects, including the WHO NCD Framework, ERS COPD Symptomatic Guidelines, and the Cardiovascular Clinical Trials Forum. He has co-authored and contributed to various published research, working closely with the Centre for Patient Reported Outcomes Research (CPROR). Additionally, he is a member of the ISPOR ‘Task Force’ focusing on emerging good practices in the use of PROs in Real World Study Design.

His interests lie particularly in the use of innovative technologies in health therapeutics, especially medical devices (MDs). Through the EU HORIZONS project, he has been involved in CORE-MD and is currently part of the HEU EFS patient working group under the European Patient Forum/Global Heart Hub initiative. His involvement in several innovative MD projects provides valuable insights into current barriers, from initiation and inception through development and early feasibility studies, to ensuring safe, ethical, and practical patient benefits as swiftly as possible.

Experience in patient advocacy:

• EPAP (European Patient Ambassador Programme).
• BHF (Cardiovascular Clinical Research Collaborative).
• GCVCT (Global Cardiovascular Clinical Trials Forum).
• GHH (Global Heart Hub -Affiliate).
• EIT Innovation & Technology (Project Reviewer/Evaluation).
• NIHR (Research Funding Application Reviewer).
• ERS (COPD Guidelines review/update).

Condition: rare eye conditions

Individual background: Russell is now a resident of France. He is A retired banker.

Experience in patient advocacy:

He became involved in patient advocacy in 2012 following his 23-year-old son’s sudden unexplained loss of sight, the eventual diagnosis of which showed that his whole family was affected by a rare genetic disorder with no approved treatment.

In addition to his work for the UK-based LHON Society, which he co-founded, Russell is an advocate for all rare eye conditions as a supporting partner of ERN-EYE and for all rare diseases as a volunteer with EURORDIS, where he serves on the DITA and HTA Task forces. He also represents EURORDIS at EMA on the Patient and Consumer Working Party and is a member of the Advisory Group on Raw Data, which is part of EMA’s Big Data programme and the multistakeholder advisory group for the ACT EU initiative aimed at accelerating clinical trials in Europe.

Committed to improving the quality of research into rare diseases, Russell’s main focus is on the provision and effective use of high-quality data generated from real-world evidence, including registries, high-quality and disease-appropriate outcome measures and improvements in the clinical trial process and outcomes.  In particular, he is anxious to see all of these tools combined and used to reinforce faster and better decision-making in the regulation and reimbursement of medicines and devices.

Condition: Type one diabetes since 2010

Individual background: Former national public health officer and drug manufacturing quality control specialist. Current researcher in public health economics, epidemiology, and health law. Interested in mitigating the socioeconomic determinants of health outcomes in paediatric and maternal sciences and in advocating for human rights to health.

Experience in patient advocacy:

• Currently working on applying the WHO framework for intrapartum care, focusing on involving women of low socioeconomic status in healthcare decision-making.
• Cofounded and actively participated (2019-2020) in the first social media platform specializing in public health awareness, reaching over 240,000 followers. Facilitated non-monetary connections between disadvantaged patients and professional medical experts across multiple countries in the EMEA region.
• Volunteered (2011-2012) to design pharmaceutical care plans, study proposals, and parent-patient counselling plans for children living with cancer.
• Provided patient counselling sessions for individuals with diabetes who aimed to lose weight, serving as an obesity management professional and sports nutrition specialist (2019-2020).