EU Medical Device Software Compliance Course

Name: EU Health Apps and Medical Device Software Compliance Training Course
Availability: InStock

Qualify, classify, document and govern health apps and medical device software across the European regulatory lifecycle.

EU Medical Device Software Compliance Course

At a glance

Duration: 1 Week
Format: Classroom
Cities: Cape town, London, Prague, Barcelona, Lisbon, Munich and more
Next session: 1 – 5 November 2026, Cape town
Average fee: 7,500 €

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EU Health Apps and Medical Device Software Compliance Training Course

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Overview

EU Health Apps and Medical Device Software Compliance Training Course is a one-week professional course for digital health, quality and regulatory teams, who leave with an EU MDSW Compliance Decision and Evidence Pack. The course connects intended purpose, qualification, Rule 11 classification, lifecycle controls, clinical evidence, cybersecurity, technical documentation, conformity and post-market governance. Participants document regulatory decisions without treating every health app as a medical device. Agile Leaders Training Center develops practical EU medical device software compliance capability.

Who Should Attend

Teams responsible for digital health product scope and intended purpose
Regulatory specialists responsible for qualification and classification decisions
Quality teams responsible for software lifecycle and risk controls
Clinical and safety teams responsible for evidence and benefit-risk reasoning
Software and cybersecurity teams responsible for verification, security and change assessment

The course assumes participants can describe a health software product and its users at work, and leaves out legal advice, medical hardware engineering and coding instruction.

Departments and Industries

The course supports departments that develop, assess or govern health apps and medical device software.

Digital health and medical technology product teams
Regulatory affairs and quality management
Clinical safety, evidence and medical affairs
Software engineering, cybersecurity and usability
Healthcare innovation, assurance and procurement

Learning Objectives

By the end of this course, participants will be able to:

Analyze intended purpose and software qualification boundaries
Apply Rule 11 and applicable classification rules
Build lifecycle, quality and risk traceability
Evaluate clinical, usability and cybersecurity evidence
Use technical documentation and conformity checkpoints
Assess post-market signals and software changes

Course Agenda

Day 1: Scope and Intended Purpose

Health App Function and User Context Map
MDR and IVDR Scope Decision Tree
Intended Purpose Statement Builder
MDCG 2019-11 Qualification Criteria Checklist
Medical Device Software Boundary Decision Record

Day 2: Classification and Regulatory Pathway

Annex VIII Implementing Rules Review
Rule 11 Decision and Harm Impact Matrix
Software Driving or Influencing a Device Assessment
Risk Class Rationale and Evidence Log
Conformity Assessment Pathway Map

Day 3: Lifecycle, Quality and Risk Controls

Software Lifecycle Process and Responsibility Map
Quality Management System Interface Matrix
Software Hazard and Risk Control Traceability
Usability Task and Use-Error Analysis
Cybersecurity Threat and Control Register

Day 4: Evidence and Technical Documentation

Clinical Evaluation and Performance Evidence Plan
Software Verification and Validation Evidence Matrix
Requirements-to-Test Traceability Review
Technical Documentation Structure Checklist
Release Readiness and Declaration Evidence Gate

Day 5: Post-Market and Change Practice

Exercise: Qualify and Classify a Health App Scenario
Exercise: Test Risk, Clinical and Cybersecurity Traceability
Exercise: Evaluate a Post-Market Signal and Corrective Action
Exercise: Assess Software Change and Documentation Impact
Capstone: EU MDSW Compliance Decision and Evidence Pack

Practical Exercises

Suggested activities use patient-monitoring, clinical decision-support and wellness-app scenarios.

Suggested activity: distinguish a general wellness function from a medical intended purpose
Suggested activity: document a Rule 11 classification rationale and uncertainty
Suggested activity: map requirements, hazards, tests and clinical evidence
Suggested activity: evaluate whether a software change affects the compliance evidence set

FAQs

Who suits EU medical device software compliance training and what does it assume?

EU medical device software compliance training suits product, regulatory, quality, clinical, software and cybersecurity teams. It assumes participants can explain a health software function, intended users and operating context, while excluding legal advice and programming instruction.

How does medical device software compliance differ from general health app development?

Medical device software compliance begins with intended purpose and qualification, then connects classification, lifecycle controls, clinical evidence, technical documentation, conformity and post-market duties. General health app development may focus on features and delivery without establishing a regulated medical purpose.

How does Rule 11 affect EU medical device software classification?

Rule 11 classifies software according to how its information supports diagnostic or therapeutic decisions, physiological monitoring and the potential consequence of an incorrect result. The classification rationale must follow the stated intended purpose and applicable implementing rules.

What evidence belongs in EU MDSW technical documentation?

EU MDSW technical documentation connects intended purpose, requirements, architecture, risk controls, verification and validation, clinical evidence, usability, cybersecurity, labeling, release decisions and post-market planning. The exact evidence depends on product scope, class and conformity pathway.

Conclusion

Participants take back an EU MDSW Compliance Decision and Evidence Pack containing intended-purpose records, qualification and classification rationales, risk traceability, evidence plans, documentation checks and post-market controls. The pack makes software compliance decisions reviewable across product functions. It also helps teams assess changes and evidence gaps before release decisions.

credits: 5 credit per day

Course Mode: full-time

Provider: Agile Leaders Training Center

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Showing 21-40 of 58 events

Location	Dates	Duration	Mode	Price
Nice	Week 10, 2027 8 – 12 March 2027	1 Week	Onsite	€8,000
Lagos	Week 10, 2027 14 – 18 March 2027	1 Week	Onsite	€6,000
Dubai	Week 11, 2027 15 – 19 March 2027	1 Week	Onsite	€6,500
Marbella	Week 11, 2027 21 – 25 March 2027	1 Week	Onsite	€6,500
Baku	Week 12, 2027 22 – 26 March 2027	1 Week	Onsite	€8,000
Langkawi	Week 12, 2027 28 March – 1 April 2027	1 Week	Onsite	€8,000
Tashkent	Week 12, 2027 28 March – 1 April 2027	1 Week	Onsite	€8,000
Berlin	Week 14, 2027 5 – 9 April 2027	1 Week	Onsite	€6,500
Bali	Week 14, 2027 11 – 15 April 2027	1 Week	Onsite	€6,500
London	Week 15, 2027 12 – 16 April 2027	1 Week	Onsite	€6,500
Sharm El-Sheikh	Week 16, 2027 19 – 23 April 2027	1 Week	Onsite	€5,200
Addis Ababa	Week 16, 2027 19 – 23 April 2027	1 Week	Onsite	€6,000
Cairo	Week 18, 2027 3 – 7 May 2027	1 Week	Onsite	€5,200
Seoul	Week 19, 2027 10 – 14 May 2027	1 Week	Onsite	€12,000
Dubai	Week 20, 2027 17 – 21 May 2027	1 Week	Onsite	€6,500
Jakarta	Week 21, 2027 24 – 28 May 2027	1 Week	Onsite	€8,000
Tokyo	Week 22, 2027 31 May – 4 June 2027	1 Week	Onsite	€12,000
Singapore	Week 22, 2027 31 May – 4 June 2027	1 Week	Onsite	€6,500
Madrid	Week 23, 2027 7 – 11 June 2027	1 Week	Onsite	€6,500
Vienna	Week 24, 2027 14 – 18 June 2027	1 Week	Onsite	€7,500

Frequently asked questions

What does this course cover?

OverviewEU Health Apps and Medical Device Software Compliance Training Course is a one-week professional course for digital health, quality and regulatory teams, who leave with an EU MDSW Compliance Decision and Evidence Pack. The course connects intended purpose, qualification, Rule 11 classification, lifecycle controls, clinical evidence, cybersecurity,…

Are training dates available?

Yes. Available dates and destinations are listed in the course dates section on this page.

How can I register?

Choose an available date on this page and complete the registration form, or send a programme enquiry.

Can I download the course brochure?

Yes. Use the brochure download link provided on this page.

EU Medical Device Software Compliance Course