Presented by
Management Forum
Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course
Learn the critical regulatory requirements and best practices for obtaining market authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) in global markets.
23-24 June 2025
+ 10-11 November 2025 »
from £1299
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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Course overview
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.
This course is part of our range of Medical Devices training courses
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 authorisation 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 authorisation 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
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
This course will cover:
Introduction to the regulations
- Overview of the regulations
- Exploratory exercise to discover the borderline between medical device, pharmaceutical, and cosmetic regulation through a case study
Is it a medical device or not?
- Medical device and in vitro diagnostic device definitions, their terminology, and software considerations
- Intended purpose and claim specificity
- Borderline between medical device software, and lifestyle and fitness software
Software qualification
- Modules and software with multiple functions
- Functional exemptions
- Population health and educational software
- Search engines, Q&A tools, and chatbots
- Resource and workflow management software
- Clinical decision software
International comparison
- Software as a Medical Device (SaMD) according to the IMDRF
- SaMD ≠ Medical Device Software
- IMDRF SaMD risk stratification framework and its pitfalls
- International differences (US, Canada, South Korea, …)
Case studies on qualification
Considerations for placement on the market
- Placing and making available on the market
- Subscription models, cloud computing, and software as a service
- Pros and cons of the modular approach
- Software platforms
- Software accessories, systems, components
- Legal status of wearables
Case study on regulatory positioning
Case study on wearables
Borderline with medicine legislation
- Companion diagnostics, medication management, and adherence apps
- Digital therapeutics
- Borderline with pharmaceuticals, combination products
Case study on borderline with medicine legislation
EU market authorisation of medical device software
- Overview of EU market authorization process
- Engaging with a Notified Body
- UDI versus Basic UDI
- EUDAMED
- Declaration of Conformity
- Person Responsible for Regulatory Compliance
- Authorized representatives
- Economic operators: distributors, importers, and service fulfillment centers
- App Stores and Digital Distribution Platforms
- Software traceability
- Monitoring critical components or platform updates
- Software recalls
- Unannounced Notified Body Audits
- Service updates, upgrades, and other changes
Case study on software distribution
Case study: a great idea for a start-up!
General safety and performance requirements for software
- Harmonised standard
- Common specifications
- GSPR Checklist
- Software labeling
- Use of language and symbols
- IT environment and mobile platforms
- Repeatability and reliability of machine learning software
- Instructions for use
Practical construction of a technical file
- Content
- Example
US market authorisation (FDA)
- US Code of Federal Regulations and its Implications for Software
- 510(k) process and de novo process
- FDA Guidances specific to software
- FDA expectations for machine learning software
Case study on US market authorisation
Discussion - international go-to-market considerations
Koen Cobbaert
Philips Healthcare
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
23-24 June 2025
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 15437
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 19 May
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
10-11 November 2025
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15438
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 06 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
United Kingdom
- Insulet International
Run Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
