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 1-20 of 58 events

Location	Dates	Duration	Mode	Price
Cape town	Week 44, 2026 1 – 5 November 2026	1 Week	Onsite	€6,000
London	Week 45, 2026 2 – 6 November 2026	1 Week	Onsite	€6,500
Prague	Week 46, 2026 9 – 13 November 2026	1 Week	Onsite	€7,500
Barcelona	Week 47, 2026 16 – 20 November 2026	1 Week	Onsite	€6,500
Lisbon	Week 47, 2026 16 – 20 November 2026	1 Week	Onsite	€6,500
Munich	Week 49, 2026 30 November – 4 December 2026	1 Week	Onsite	€6,500
Tbilisi	Week 52, 2026 21 – 25 December 2026	1 Week	Onsite	€5,700
Istanbul	Week 53, 2026 28 December 2026 – 1 January 2027	1 Week	Onsite	€6,000
Frankfurt	Week 01, 2027 4 – 8 January 2027	1 Week	Onsite	€6,500
Zanzibar	Week 01, 2027 10 – 14 January 2027	1 Week	Onsite	€6,000
Rome	Week 02, 2027 11 – 15 January 2027	1 Week	Onsite	€6,500
Manama	Week 02, 2027 17 – 21 January 2027	1 Week	Onsite	€6,500
Johannesburg	Week 02, 2027 17 – 21 January 2027	1 Week	Onsite	€6,000
Kuwait	Week 04, 2027 31 January – 4 February 2027	1 Week	Onsite	€7,000
Trabzon	Week 05, 2027 7 – 11 February 2027	1 Week	Onsite	€8,000
Kuala Lumpur	Week 06, 2027 8 – 12 February 2027	1 Week	Onsite	€6,500
Paris	Week 07, 2027 15 – 19 February 2027	1 Week	Onsite	€6,500
Abu Dhabi	Week 07, 2027 15 – 19 February 2027	1 Week	Onsite	€6,500
Muscat	Week 07, 2027 21 – 25 February 2027	1 Week	Onsite	€6,500
Phuket	Week 08, 2027 28 February – 4 March 2027	1 Week	Onsite	€8,000

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