Strengthen your MDR clinical strategy from evidence planning to PMCF
A practical online training for Clinical and Regulatory professionals who need stronger evidence logic, clearer lifecycle alignment, and confidence when preparing for clinical evaluation, PMCF, PMS, SSCP, clinical investigations, QMS interfaces, and Notified Body expectations.
Registration is completed through secure Stripe checkout.
Strengthen your clinical strategy with a more proactive lifecycle approach.
Under the EU MDR, clinical evidence must be planned, justified, updated, and connected across the full product lifecycle.
Intended purpose, claims, clinical evaluation, risk management, PMS, PMCF, SSCP, vigilance, clinical investigations, and QMS processes must all support a single coherent regulatory story.
A more proactive and streamlined evidence strategy can help teams reduce avoidable rework, improve consistency across documentation, and prepare more confidently for Notified Body review.
This training helps Clinical and Regulatory professionals strengthen MDR evidence generation strategy from early planning through post-market follow-up.
Strengthen the clinical evidence strategy behind sustained MDR compliance.
- Connect clinical strategy, clinical evaluation, PMS, PMCF, SSCP, risk management, and QMS into one lifecycle approach.
- Plan and maintain clinical evidence across pre-market and post-market phases.
- Strengthen CEP, CER, PMCF, PMS, PSUR, SSCP, and related clinical documentation.
- Recognize where Notified Bodies may identify gaps, inconsistencies, or weak clinical justifications.
- Prepare more confidently for Notified Body questions, audit findings, documentation updates, and certification maintenance.
Complete course or selected modules.
This modular online course covers the clinical lifecycle of medical devices under the EU MDR.
Participants can choose the complete training path or select individual modules based on their role, responsibilities, and current priorities.
Full training path
- 6 modules
- 24 total training hours
- Delivered over 6 training dates
Individual modules
- Selected modules available
- Live online | 4 hours per module
- Designed for focused learning around specific MDR clinical compliance topics
Included with the training
Registration is completed through secure Stripe checkout.
Choose the full path or the modules that match your priorities.
The full course covers the clinical lifecycle end-to-end. Individual modules can be selected for focused training on MDR clinical strategy, evaluation, PMCF, PMS, clinical investigations, SSCP, consultations, and QMS alignment.
Regulatory framework + QMS for clinical activities
Covers the MDR regulatory framework for clinical aspects, including roles, responsibilities, requirements, definitions, MDCG documents, and national legal requirements, together with SOPs, templates, outsourced clinical processes, auditing of clinical aspects, and alignment with EN ISO 13485.
Clinical strategy and evaluation across the lifecycle
Time: 2:00–6:00 PM Central European Time
Covers clinical strategy and clinical evaluation across the lifecycle, including the concept of clinical evidence and how clinical strategy supports evidence planning and lifecycle compliance from pre-market to post-market.
Deep dive in clinical evaluation and evidence
Time: 2:00–6:00 PM Central European Time
Covers clinical evaluation methods and processes, including CEP, SOTA, CER, clinical data collection, appraisal and analysis, literature review, equivalence considerations, and the link between clinical evaluation and PMCF.
SSCP + clinical evaluation consultations
Time: 2:00–6:00 PM Central European Time
Summary of Safety and Clinical Performance — SSCP
Covers SSCP content and structure for professionals and laypersons, links to clinical evaluation and PMCF, updating, maintenance, and publication.
Clinical Evaluation Consultations
Covers expert panel consultations, voluntary and mandatory clinical evaluation consultations, orphan device consultations, and other consultation pathways.
Clinical Investigations and PMCF studies
Time: 2:00–6:00 PM Central European Time
Covers types of clinical investigations and PMCF studies, study strategy, CIP, synopsis, CIR, SCIR, competent authority and ethics committee involvement, safety reporting, PRRC responsibilities, and interfaces with EN ISO 14155 and ISO 14971.
Mastering PMS and PMCF design and execution
Time: 2:00–6:00 PM Central European Time
Covers vigilance, PMS, PSUR, SSCP updates, PMCF plans, PMCF methods, PMCF reports, and CEP/CER updates.
This module focuses on how post-market activities feed back into clinical evaluation, risk management, SSCP maintenance, and lifecycle evidence strategy.
Core Clinical Training x 6
€1,896.00
20% off single module pricing
Register for 6 modulesCore Clinical Training x 3
€1,066.00
10% off single module pricing
Register for 3 modulesCore Clinical Training x 1
€395.00
Standard single module pricing
Register for 1 module
Learn from practical MDR and Notified Body experience.
This training is led by Susanne Gerbl-Rieger, who brings long-standing experience in clinical auditing and Notified Body work from her role as a clinical auditor and expert at TÜV SÜD.
Susanne has worked alongside manufacturers, Notified Bodies, and regulators, supporting organizations across EU MDR clinical evaluation, evidence generation, and PMCF. She now helps MedTech teams translate evolving regulatory expectations into practical, scalable clinical strategies.
Designed for Clinical and Regulatory professionals working under EU MDR.
This training is especially relevant for professionals responsible for clinical evidence, clinical evaluation, regulatory strategy, post-market activities, technical documentation, and MDR compliance decision-making.
Recommended for:
- Clinical and Regulatory Affairs professionals;
- PMS and PMCF owners;
- Medical Affairs and Scientific Affairs professionals;
- Quality/QMS professionals involved in clinical process alignment;
- Product, R&D, and leadership stakeholders involved in MDR evidence decisions.
This training is especially useful if you are preparing or updating CEP, CER, SSCP, PSUR, PMCF plans, PMCF reports, clinical investigations, or Notified Body responses.
Registration is completed through secure Stripe checkout.
Strong clinical strategy is part of regulatory capability.
AKRA Team helps MedTech organizations make timely, well-informed regulatory and clinical decisions across products, markets, and the full product lifecycle.
This training reflects AKRA’s broader approach: helping teams strengthen internal capability, improve decision-making, and navigate regulatory complexity with confidence.
For Clinical and Regulatory professionals, that means moving beyond isolated documents and building clinical evidence logic that remains coherent, defensible, and usable throughout the lifecycle.
Register for the full course or selected modules.
Choose the complete training path to cover MDR clinical strategy across the full device lifecycle or select the modules most relevant to your current priorities.
Dates:
23 September – 2 October 2026
Format:
Live online training
Schedule:
2:00–6:00 PM Central European Time
Full course:
6 modules | 24 hours | 6 training dates
Individual modules:
Selected modules available
Included:
Presentation decks, reference checklists, knowledge quizzes, and completion certificate.
Strengthen your MDR clinical strategy before the next critical review.
EU MDR clinical compliance is about your evidence strategy remaining coherent, defensible, and connected from evidence planning to PMCF.
Register for the complete course or select the modules most relevant to your current MDR priorities.
Core Clinical Training x 6
€1,896.00
20% off single module pricing
Register for 6 modulesCore Clinical Training x 3
€1,066.00
10% off single module pricing
Register for 3 modulesCore Clinical Training x 1
€395.00
Standard single module pricing
Register for 1 moduleSecure registration and payment are completed through Stripe.