Course overview
Master the critical decisions that shape your software’s regulatory success. Every choice you make, from product claims to technology selection and regulatory positioning, can determine the outcome of your market authorisation process. Missteps can mean costly delays, increased development expenses and even denied market entry. This course gives you the clarity and confidence to avoid these pitfalls and ensure your innovation achieves its full global potential.
With emerging technologies such as digital therapeutics, machine learning and cloud computing, navigating the regulatory landscape has never been more complex. Distinguishing medical from non-medical software, defining clinical validation needs, understanding international regulatory differences and meeting diverse market authorisation requirements are just some of the challenges you will tackle.
This course offers a clear, practical understanding of global medical device software regulations. Through expert-led sessions, hands-on exercises and real-world case studies, you will gain the insights and skills needed to confidently steer your software through regulatory pathways and bring it successfully to market.
You will also explore best practices for developing and managing regulated software and learn how to implement them effectively without stifling innovation. Discover how to balance flexibility in the early stages of design with the rigorous oversight needed to deliver a final build that is safe, reliable and fully compliant. This nuanced approach is difficult to master without practical experience and informed guidance, and that is exactly what this course provides.
Led by industry experts with extensive hands-on experience, you will leave equipped with the strategies and knowledge to transform your development process and ensure your products meet the highest standards of quality and safety.
Don’t miss this opportunity to strengthen your expertise and drive successful medical device software projects. Register today to secure your place.
CPD Hours: 30
Course Content
- Day 1
- Welcome - introduction to the regulations
- Is it a medical device, or not?
- Software qualification
- International comparison
- Case studies on qualification
- Considerations for placement on the market
- Case study on regulatory positioning
- Case study on wearables
- Borderline with medicine legislation
- Case study on borderline with medicine legislation
- Day 2
- EU market authorisation of medical device software
- Case study on software distribution
- Case study: a great idea for a start-up!
- General Safety and Performance Requirements for software
- Practical Construction of a Technical file
- US Market authorisation (FDA)
- Case study on US market authorization
- Discussion - International go-to-market considerations
- Day 3
- Classification of Medical Device Software
- Case studies - Classification
- Borderline cases
- Software Development Models
- Best practices to manage design activities
- State-of-the-art standards for regulatory compliance
- Software Development Standards for regulatory compliance
- Managing software suppliers and subcontractors
- Day 4
- Software usability
- User experience evaluation techniques
- Safety Risk Management
- Risk Control
- Case study on risk identification
- Risk assessment & evaluation
- Risk management throughout the product lifecycle
- Risk perception and communication
- Day 5
- Core concepts in clinical evaluation of medical software
- Setting the right scope and level of evidence for medical software
- The literature review process
- Case Studies - clinical evaluation of medical device software
- Assessing and documenting clinical evidence: The Clinical Evaluation Report
- Clinical and performance studies
- Post-Market Surveillance and Post-Market Clinical Follow up
Speakers
Koen Cobbaert
Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.
In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing its members at respectively the European Commission MDCG workgroups on Borderline and Classification and New Technologies and at the international level at the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. Koen is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP). Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data (AI Act, Machinery Regulation, General Product Safety Directive, Data Act, European Health Data Space…). Aside from various publications through trade associations, Koen also edited the book Software as a Medical Device, published through the Regulatory Affairs Professionals Society (RAPS).
In the standardization domain, Koen is a member of CEN-CENELEC’s Industry Advisory Forum, and he is delegated as a Belgian expert to IEC JTC 1 SC 42 on artificial intelligence, CEN-CENELEC JTC21 on artificial intelligence, ISO TC215 JWG7 on health informatics, and to the IEC SC62A Advisory group on Software, Networks, and Artificial Intelligence (SNAIG).
Koen has a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions, and moderating risk management and clinical evaluation for software applications for general radiology, oncology, neurology, cardiology, orthopaedics, and clinical pathology. He has worked on software applications for pattern recognition, computer-aided detection, reasoning engines, clinical pathways, and other clinical decision support systems, including mobile apps, embedded software, and software operating in the cloud.
Zuzanna Kwade
Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.
Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.
