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Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

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

Need help?  Enrol/reserve

Course overview

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:

  • managing software suppliers
  • designing and evaluating the product’s user experience
  • managing safety risks
  • state-of-the-art standards like IEC 62304 and IEC 82304-1
  • techniques for effective risk control and communication

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.

Benefits of attending

By attending this course you will:

  • Learn best practices for compliant software development and management while keeping the administrative burden at bay
  • Examine essential techniques to improve product quality and ensure business continuity given employee turnover and continuously changing IT environments
  • Consider the advantages of automating documentation practices
  • Identify real-world stories to help you motivate your team to follow best practices rather than threatening them with looming regulatory findings
  • Get up to date with how state-of-the-art standards are evolving
  • Master user experience evaluation techniques
  • Get to grips with risk management terminology, techniques and strategies
  • Understand how to communicate in times of crises

Who should attend?

Professionals involved in software development and regulatory compliance withing the medical device industry, including:

  • Software developers
  • Project managers
  • Product managers
  • System analysts
  • Biomedical engineers
  • Risk management moderators
  • Clinical validation specialists
  • Usability engineers
  • Technical writers
  • Regulatory affairs specialists
  • Quality assurance engineers
  • Clinical informatics managers of hospitals

Enrol/reserve

This course will cover:

Software development models

  • Symptoms and root causes of poor design control
  • Waterfall vs agile, iterative, and spiral development
  • Principles of good design control
  • Stage-gated models

Best practices to manage design activities

  • Project management
  • Development planning
  • Change management
  • Requirements management
  • Architecture and design
  • Development
  • Configuration management
  • Verification and validation
  • Defect management
  • Design reviews

State-of-the-art standards for regulatory compliance

  • Software development standards for regulatory compliance
    • IEC 62304 software lifecycle management
    • IEC 82304-1 General requirements for product safety

Managing software suppliers and subcontractors

  • Managing software suppliers
  • Outsourcing design activities
  • Identifying critical suppliers
  • Managing software platforms and plugins
  • Using open-source software
  • Using legacy software

Software usability

  • Managing the human element of risk
  • Designing for happiness
  • Terminology, roles and responsibilities
  • Human factors engineering
  • User Experience Design (UXD)
  • Process

User experience evaluation techniques

  • Formative evaluation
    • User observations
    • Walkthroughs
    • Heuristic review
    • Key-stroke level model
  • Summative evaluation
    • Product reaction cards / word association
    • Single Ease Question (SEQ)
    • System Usability Score (SUS)
    • Interface with risk management
  • Regulatory requirements and standards
    • EU MDR/IVDR requirements
    • US FDA requirements
    • IEC 62366-1, etc.
    • Usability guides

Safety risk management

  • Process, terminology, roles
  • Risk identification methodologies 
    • Checklists
    • Grey box
    • Hazard and Operability Analysis (HAZOP)
    • Failure Mode and Effects Analysis (FMEA)
    • Fault Tree Analysis (FTE)

Risk control

  • Risk reduction paradigms
  • Risk reduction under single fault condition
  • Inherently safe design
  • Preventive measures
  • Corrective measures
  • Mitigations
  • Safety notices
  • Disclosures of residual risk
  • Risk control strategies

Case study on risk identification

Risk assessment and evaluation

  • IMDRF terminology
  • Determining severity and probability of harm
  • Determining if a risk is acceptable
  • Benefit-risk assessment
  • Risk management deliverables

Risk management throughout the product lifecycle

  • Risk management throughout the product lifecycle
  • Risk management of ESCs, SOUPs, COTS and platforms

Risk perception and communication

  • Involving external stakeholders in assessing risk
  • Communication in times of crisis

Enrol/reserve

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.

More details

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

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

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 05 Jun

View basket 

 
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

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 09 Oct

View basket 

 
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

  • SPD

Enrol/reserve

Run Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 500
  • 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:

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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy