Qualification & intended purpose
Determine whether software is likely to qualify as MDSW and draft a defensible intended-purpose statement.
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EU MDR Readiness for Medical Device Software
Build a practical regulatory-readiness roadmap—from intended purpose and Rule 11 to technical documentation, clinical evidence and lifecycle control.
Self-paced · Approximately 10–12 hours · Professional development
The outcome
Leave with a roadmap—not only notes
The course is designed around one professional outcome: a structured EU MDR readiness plan for a medical-device software product.
- Draft and review a medical-device software intended purpose
- Document an initial MDSW qualification rationale
- Apply MDR Rule 11 to realistic software cases
- Select a conformity-assessment strategy
- Build a technical-documentation structure and evidence gap register
- Plan clinical evaluation, PMS and software-change controls
Eight-module curriculum
From product claim to lifecycle control
Each module adds a practical component to the learner’s Regulatory Readiness Workbook.
MDR classification & Rule 11
Apply software classification principles and document the consequence of clinical decisions.
Regulatory strategy
Map economic operators, PRRC responsibilities, conformity assessment and Notified Body preparation.
Compliance evidence system
Connect GSPRs, quality, risk, lifecycle, usability and cybersecurity evidence.
Clinical evaluation
Build claims-to-evidence traceability and identify important clinical evidence gaps.
Technical documentation
Structure Annex II and III evidence and prepare for review questions.
UDI, EUDAMED & market entry
Plan registration, labelling and release-to-market activities.
Post-market & change control
Control monitoring, vigilance, cybersecurity updates and software changes.
Bonus moduleAI-enabled medical-device software
Understand the developing relationship between the EU MDR, IVDR and EU AI Act without treating AI as a substitute for medical-device analysis.
The learning experience
Designed for independent, active learning
Progress is saved so learners can stop and return. Required activities and quizzes build toward the final examination.
- 01Learn
Short lessons explain the regulatory decision and its practical context.
- 02Decide
Interactive cases ask you to choose and defend the best regulatory conclusion.
- 03Apply
Editable tools build a reusable Regulatory Readiness Workbook.
- 04Check
Knowledge tests provide immediate explanations, not only a score.
- 05Demonstrate
A final examination confirms the required learning threshold.
Assessment & certificate
A completion standard that means something
Learners must meet the pass requirement before progressing.
Approximately forty randomised questions, including applied scenarios.
The planned certificate will include a unique number and verification record.
The Certificate of Successful Completion confirms completion of the course and its assessments. It is not an EU regulatory approval, CE certificate, Notified Body certificate, professional licence or academic qualification.
Who it is for
Built for global teams entering the European market
Medical-device software and AI founders
Regulatory and quality professionals
Product managers and software leads
Consultants supporting digital health
Professionals entering regulatory affairs
Course launch list
Help shape the founding edition
Register your interest to receive launch information. Early responses will also help determine the most useful examples, job aids and corporate enrolment options.
- No payment is taken at this stage
- No obligation to enrol
- Individual and team interest welcome