Dec 3 • Katie Cooney & Breda Kearney
EU-MDR Clinical Evaluation of Software as a Medical Device (SAMD): Bringing it back to basics
What you’ll learn in this informative EU MDR SaMD webinar
The session starts with how to determine whether software is regulated under the MDR and meets the definition of a medical device in Article 2, using MDCG 2019-11 and MDCG 2020-1 as the key guidance documents for qualification and deciding whether a stand-alone clinical evaluation is required.
It then explains what the MDR means by clinical evaluation: a systematic, planned, and continuous process to generate, collect, analyse and assess clinical data to confirm the device is safe, performs as intended and delivers a clinical benefit.
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The webinar outlines the steps in this process, including preparing the clinical evaluation plan, identifying, and appraising available data, generating new data where needed and completing the clinical evaluation report.
A core part of the session covers the three elements of clinical evidence that software must demonstrate: valid clinical association, technical performance and clinical performance. It describes how to establish that the software’s output is clinically relevant, that the device reliably generates the intended technical output and what happens when it is used by the intended users in the intended clinical setting.
The webinar also addresses how to define a clear intended purpose and clinical benefit, noting that for software the clinical benefit often relates to providing information to support diagnosis, as described in MDCG 2020-1. It then walks through how to define the state of the art by looking at the clinical condition, current care pathways, alternative options and similar devices, and how this is used to set performance and safety objectives.
The differences between clinical data and non-clinical data are explained, including why retrospective testing of pre-labelled datasets is useful for technical performance but is not clinical data for demonstrating clinical performance. Case examples illustrate how evidence requirements vary depending on the device’s intended purpose, risk and novelty.
Finally, the session shows how post-market surveillance (PMS) and post market clinical follow up (PMCF) feed back into clinical evaluation, with real-world data from complaints, vigilance, feedback, literature and planned PMCF activities used to update the clinical evaluation and risk management file as part of the ongoing cycle.
The webinar also addresses how to define a clear intended purpose and clinical benefit, noting that for software the clinical benefit often relates to providing information to support diagnosis, as described in MDCG 2020-1. It then walks through how to define the state of the art by looking at the clinical condition, current care pathways, alternative options and similar devices, and how this is used to set performance and safety objectives.
The differences between clinical data and non-clinical data are explained, including why retrospective testing of pre-labelled datasets is useful for technical performance but is not clinical data for demonstrating clinical performance. Case examples illustrate how evidence requirements vary depending on the device’s intended purpose, risk and novelty.
Finally, the session shows how post-market surveillance (PMS) and post market clinical follow up (PMCF) feed back into clinical evaluation, with real-world data from complaints, vigilance, feedback, literature and planned PMCF activities used to update the clinical evaluation and risk management file as part of the ongoing cycle.
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Meet Your
Industry Expert
Rod
Beuzeval
Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices.
Rod has a bachelor’s degree with first class honours in engineering and management. He also holds the prestigious Regulatory Affairs Certification (Global Scope) from the Regulatory Affairs Professionals Society and is a Lean Sigma Green Belt. Rod has worked in the medical device and pharmaceutical industry for over 22 years, including time spent in some of the largest medical device and pharmaceutical manufacturers.
Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP.
Rod’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients update their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP and QMS systems.
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About John
John received his degree in Chemistry and Microbiology from University of Ireland, Galway in 1997.
He then began his career in MedTech as a product builder, assembling one of the first vascular stents, from which he quickly moved into the Quality department as a Quality Inspector.
Since that time John has moved up through the Quality & Regulatory ranks to site leadership level, while also working across a wide spread of small, medium and large multi-national medical technology organisations, and with an equally wide spread of different medical technologies.
John is passionate about simplifying quality and regulatory challenges for industry, which consequently led him to set up Atlas Quality in February 2020.
Since setting up Atlas, among other things, John has assisted multiple organisations with Internal Audit, CAPA, QMS, Risk Management and MDR remediations, lectured on Quality Management Systems in ATU, Galway and University of Limerick, and has presented at international conferences on the MDR & Risk Management.
About Aaron
Aaron currently works as the Vice President of Quality Assurance located in Boston Massachusetts. Prior to this, he worked at Fresenius-Kabi, Molnlycke Healthcare, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of medical devices from simple class I disposable medical devices to advanced class III surgical instruments, human tissue implants, and sterile IV pharmaceuticals.
He has over 20 years of medical device manufacturing experience which includes 10 years of compliance auditing and 9 years managing quality teams.
He is an experienced trainer that has led multiple training workshops in process validation, CAPA, failure investigation, and quality auditor while at Molnlycke, Waters, and Covidien.
He is an expert in medical device quality management systems and an experienced quality executive.
He has over 20 years of medical device manufacturing experience which includes 10 years of compliance auditing and 9 years managing quality teams.
He is an experienced trainer that has led multiple training workshops in process validation, CAPA, failure investigation, and quality auditor while at Molnlycke, Waters, and Covidien.
He is an expert in medical device quality management systems and an experienced quality executive.
About Richard
Richards’ core skills can be broadly divided into 4 main areas
- Regulatory Affairs
- GMP (Quality Assurance)
- GLP (Laboratory Testing)
- GCP (Clinical)
These core skill areas have been developed over 25 years of experience with products ranging from class 3 devices such as Orthopedic implants (IIb) neurological robots, through electromedical devices such as infusion systems and cardio vascular products.
Richard brings a blend of pragmatism and experience to these disciplines that facilitates insightful problem solving approaches as well as solid solutions.
Richard has also had broad experience in a wide range of materials and manufacturing technologies including sterilisation, plastic moulding, software development, electronic medical devices, ceramics, CNC machining, plasma coatings, packaging, extrusion and automated assembly.
Based on this wealth of experience, Richard is able to support a broad range of services as well as the ability to manage projects on behalf of your organisation.
Richard has also had broad experience in a wide range of materials and manufacturing technologies including sterilisation, plastic moulding, software development, electronic medical devices, ceramics, CNC machining, plasma coatings, packaging, extrusion and automated assembly.
Based on this wealth of experience, Richard is able to support a broad range of services as well as the ability to manage projects on behalf of your organisation.
About Rod
Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices.
Rod has a bachelor’s degree with first class honours in engineering and management. He also holds the prestigious Regulatory Affairs Certification (Global Scope) from the Regulatory Affairs Professionals Society and is a Lean Sigma Green Belt. Rod has worked in the medical device and pharmaceutical industry for over 22 years, including time spent in some of the largest medical device and pharmaceutical manufacturers.
Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP.
Rod’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients update their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP and QMS systems.
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About Katie
Katie has over 22 years of experience in the Life Sciences industry, beginning her career at Boston Scientific before progressing into training, learning and organisational development roles across global medical device and pharmaceutical companies including Integer and Astellas Pharma.
Her experience spans training strategy, instructional design, LMS implementation, behavioural change initiatives, leadership development and global learning operations.
Prior to founding Leap Compliance, Katie served as General Manager of a MedTech QA/RA training company, leading business growth, client delivery and the development of regulatory and compliance training solutions for the life sciences sector.
Prior to founding Leap Compliance, Katie served as General Manager of a MedTech QA/RA training company, leading business growth, client delivery and the development of regulatory and compliance training solutions for the life sciences sector.
Katie holds a degree in HR and a diploma in Leadership and Executive Coaching. She is an experienced instructional designer with expertise in competency frameworks, coaching, mentoring and the design of engaging learning solutions across virtual, classroom, eLearning and blended formats.
Passionate about making complex subjects understandable, Katie focuses on delivering practical, engaging training that drives behavioural change and delivers measurable impact.
Passionate about making complex subjects understandable, Katie focuses on delivering practical, engaging training that drives behavioural change and delivers measurable impact.
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About Colleen
Colleen is a Senior Instructional Designer and e-Learning Developer with over 20 years of experience creating engaging, performance-focused learning solutions for the life sciences, pharmaceutical, medical device, and healthcare sectors.
Colleen began her career developing e-Learning solutions for the US Department of Defense, an experience that established her commitment to precision, compliance, and rigorous instructional standards.
She went on to apply that same rigour in clinical research, leading instructional design projects for clinical trial staff. She later brought these skills to a specialist life sciences consultancy, where she designed bespoke quality and regulatory learning solutions for medical device manufacturers, developing training aligned with global standards, industry requirements, and client-specific compliance needs.
She went on to apply that same rigour in clinical research, leading instructional design projects for clinical trial staff. She later brought these skills to a specialist life sciences consultancy, where she designed bespoke quality and regulatory learning solutions for medical device manufacturers, developing training aligned with global standards, industry requirements, and client-specific compliance needs.
Colleen’s portfolio spans needs analysis, instructional design, e-Learning development, assessment design, and LMS management, delivered across multiple modalities, from digital and e-Learning formats to blended and instructor-led programmes.
Colleen brings both the technical depth and the regulatory awareness that life sciences organisations need to build truly effective compliance training.
About Niamh
Niamh is a Medical Device QA/RA and Software expert with over 30 years of experience across the life sciences and MedTech sectors. Her expertise spans medical device software, AI-enabled technologies, regulatory compliance, quality assurance and international standards development.
Niamh holds a BSc (Hons) in Artificial Intelligence/Cognitive Science, an MScSED in Software Engineering and Database Technologies, and is currently a PhD Candidate specialising in AI-enabled Medical Device Regulatory Requirements. She is a published author in the field of AI-enabled medical devices and a recognised thought leader within the MedTech industry.
She currently serves as Chair of TC10 Medical Equipment, Software and Systems, representing Ireland internationally through IEC and CEN-CENELEC standards committees.
Niamh is also a keynote speaker across MedTech Europe and Ireland and previously worked as a Notified Body Technical Reviewer for active medical devices, including software applications. Passionate about innovation, regulation and emerging technologies, she brings deep technical and regulatory expertise to complex healthcare and software environments.
Niamh is also a keynote speaker across MedTech Europe and Ireland and previously worked as a Notified Body Technical Reviewer for active medical devices, including software applications. Passionate about innovation, regulation and emerging technologies, she brings deep technical and regulatory expertise to complex healthcare and software environments.