Certified MDR Compliance Specialist (CMDRS) Certification Program by Tonex
This program builds deep competence in the EU Medical Device Regulation, from product classification and intended use to clinical evaluation, technical documentation, and post-market surveillance. Participants learn how to map gaps, structure conformity assessment strategies, and work effectively with notified bodies across device lifecycles. Emphasis is placed on risk management aligned to ISO 14971 and robust quality system integration for MDR readiness.
The course addresses the growing convergence of software, AI, and connected devices, highlighting data integrity and incident reporting expectations. It explains how secure design and vigilance processes reduce exposure to data breaches and operational risks. Cybersecurity considerations are woven throughout to strengthen safety, performance, and patient trust.
Learning Objectives
- Explain MDR scope, definitions, and key obligations
- Determine classification using rules and intended purpose
- Build compliant technical documentation and GSPRs traceability
- Plan conformity routes and notified body interactions
- Implement PMS and vigilance aligned to ISO 14971
- Integrate usability, clinical evaluation, and QMS alignment
- Strengthen device security posture and data protection for cybersecurity
Audience
- Regulatory Affairs Specialists
- Quality Assurance Managers
- Clinical and Risk Management Leads
- Medical Device Engineers and Product Owners
- Notified Body and Supplier Liaisons
- Cybersecurity Professionals
- Compliance Officers and Consultants
Course Modules
Module 1: MDR Foundations And Scope
- MDR structure, definitions, stakeholders
- Economic operators roles, obligations
- Intended purpose, claims substantiation
- GSPRs overview, Annex I mapping
- Legacy, orphan, transitional devices
- UDI basics, EUDAMED overview
Module 2: Classification And Borderlines
- Classification rules, rationales, pitfalls
- Active, implantable, reusable considerations
- Software as medical device criteria
- Companion diagnostics, substance devices
- Borderline determination case patterns
- Reclassification impact on pathways
Module 3: Technical Documentation Essentials
- Annex II structure and expectations
- GSPRs checklist, evidence linkage
- Design dossier, specifications, verifications
- Clinical evaluation, CER alignment
- Risk files integration with ISO 14971
- IFU labeling, UDI data completeness
Module 4: Conformity Assessment Pathways
- Annex IX full QMS audit approach
- Annex X type examination essentials
- Annex XI production quality assurance
- Notified body selection, readiness, audits
- Sampling, surveillance, unannounced audits
- Certificates scope, validity, changes
Module 5: Post-Market And Vigilance
- PMS plan, PMCF plan, reports
- PSUR creation, frequency, content
- Trend reporting, serious incidents
- FSCAs, FSNs, timelines, coordination
- Supply chain feedback integration
- Continuous improvement with KPIs
Module 6: Software And Cybersecurity Compliance
- SaMD classification, lifecycle control
- Secure by design requirements integration
- SBOM, patching, update governance
- Data protection, integrity, retention
- Clinical performance for software features
- Post-market monitoring for cybersecurity
Exam Domains
- MDR Legal Framework And Governance
- Device Classification And Borderline Analysis
- Technical Documentation And GSPRs Traceability
- Conformity Assessment And Notified Body Audits
- Post-Market Surveillance And Vigilance Operations
- Software Compliance And Secure Design Controls
Course Delivery:
The course is delivered through a combination of lectures, interactive discussions, workshops, and project-based learning, facilitated by experts in the field of Certified MDR Compliance Specialist. Participants will have access to online resources, including readings, case studies, and tools for practical exercises.
Assessment and Certification:
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified MDR Compliance Specialist.
Question Types:
- Multiple Choice Questions (MCQs)
- Scenario-based Questions
Passing Criteria:
To pass the Certified MDR Compliance Specialist Certification Training exam, candidates must achieve a score of 70% or higher.
Ready to lead MDR compliance with confidence and build safer, more secure devices? Enroll now in the CMDRS Certification Program by Tonex and accelerate your path to approval and market success.