Presented by
Management Forum
Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.
10 July 2025
+ 13 November 2025 »
from £649
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Master best practices in regulated software development so that you can balance flexibility and control, enabling innovation early on while ensuring rigorous oversight and regulatory compliance as projects progress.
Best practices for the development and management of regulated software are straightforward, but the challenge lies in effectively implementing them without stifling creativity. This skill is essential for delivering a final build that is reliable, safe, and compliant with regulatory requirements. Early on, allow your team to explore and experiment—later, tighten the reins, meticulously assess code impacts, and conduct targeted testing to maintain system integrity without incurring exorbitant costs or risking regulatory implications. This nuanced balance is best learned through practical experience and informed guidance, which this course offers in abundance.
From studying different software development models and managing design activities to understanding state-of-the-art standards and effective outsourcing strategies, you will gain insights to avoid the pitfalls of poor software development. Practical case studies will illuminate real-world challenges and solutions, guiding you through the complexities of regulatory compliance and optimal project management. Led by an expert with extensive hands-on experience, this course provides the strategies and knowledge to transform your development process, ensuring your products meet the highest standards of quality and safety.
This course covers crucial topics such as:
Through hands-on case studies and expert-led discussions, you’ll learn to navigate the complex regulatory landscape and apply proven strategies to ensure your software’s success. Whether tackling system usability or evaluating risks throughout the product lifecycle, this course provides the tools and knowledge you need.
Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.
By attending this course you will:
Professionals involved in software development and regulatory compliance withing the medical device industry, including:
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:
Please contact us for pricing if you are interested in booking 5 or more delegates
10 July 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 15443
Until 05 Jun
Not ready to book yet?
for 7 days, no obligation
13 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 15444
Until 09 Oct
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
1 day
Typical duration
Pricing from:
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:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: