Join this two-day training course to master the intricate decisions on product claims, technologies, and regulatory positioning that software manufacturers face.
These choices significantly impact the market authorisation process and can determine your success. Avoid missteps that lead to delays, increased costs, and denied market entry. Ensure your innovation reaches its full potential worldwide.
Emerging technologies like digital therapeutics, machine learning, and cloud computing add layers of complexity. Distinguishing between medical and non-medical software, understanding international differences, and meeting diverse market authorisation requirements are some of the significant challenges you’ll encounter.
In this course, you will gain a clear understanding of global medical device software regulations. We'll provide practical insights, hands-on exercises, and case studies to guide you through the intricate decisions needed that affect your market authorisation processes. You'll leave equipped to confidently bring your software to market and ensure its regulatory success.
Benefits of attending
By attending this course, you will:
- Examine the borderline between general health and wellness, medical and pharmaceutical software.
- Master the criteria that qualify software as a medical device
- Learn how claim and technology decisions are linked to market authorization obligations
- Get to grips with the regulatory concepts of configurable devices, accessories, systems, and parts, and how leveraging them for your regulatory positioning can impact your administrative burden
- Identify the pros and cons of splitting your software into platforms and modules
- Expand your understanding of the EU and US market authorization process and its obligations for software products
- Get up to date with how different distribution models such as direct download, app stores, cloud-based, and subscription models bring different economic operator obligations
- Understand a health institution’s obligations, opportunities and limitations for in-house development
- Place yourself in the shoes of a start-up and weigh your regulatory options, strategy, timing, and budget decisions
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Koen Cobbaert,
Philips HealthcareKoen 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 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.
Who Should Attend
- Business strategists
- Product and service managers
- Sales and marketing managers
- Regulatory affairs managers
- Legal professionals
- Compliance officers
- Research and development engineers
- Clinical research associates
- Project managers
- Clinical informatics managers of hospitals
