Certified IVD Compliance Specialist (CIVDS) Certification Program by Tonex
This program equips professionals to navigate EU IVDR 2017 746 with practical clarity across classification conformity assessment performance evaluation and post market follow up. Participants learn how to structure robust technical documentation align with notified body expectations and implement quality management systems that withstand audits. The course connects clinical evidence generation with real world performance studies and trend reporting to support continuous compliance.
Cybersecurity is addressed as an intrinsic part of safety and performance for software and connected IVDs covering threat modeling secure update practices and incident readiness. Learners gain methods to integrate cybersecurity risk controls into device lifecycle documentation PMS plans and vigilance processes ensuring resilient products and trusted data.
Learning Objectives
- Interpret IVDR scope definitions and device classification
- Select appropriate conformity assessment routes with rationale
- Build technical documentation that aligns with Annexes II and III
- Plan and execute performance evaluation and clinical evidence activities
- Establish PMS and vigilance systems with effective trending
- Collaborate effectively with notified bodies and competent authorities
- Integrate cybersecurity risk management into IVD lifecycle and PMS
Audience
- Regulatory affairs specialists
- Quality managers and QMS auditors
- Clinical and performance evaluation leads
- R D and product managers
- Medical device software and data engineers
- Cybersecurity Professionals
- Compliance consultants and project leads
Program Modules
Module 1: Understanding IVDR Scope and Definitions
- IVD categories and scope
- Intended use statements
- Companion diagnostics overview
- Software as IVD basics
- Economic operators roles
- Transition timelines planning
Module 2: Device Classification and Intended Use
- Classification rules mapping
- Borderline and accessories
- Reclassification pitfalls
- Risk benefit considerations
- Labeling and IFU links
- Use cases and claims
Module 3: Conformity Assessment Routes Selection
- Route options summary
- Notified body engagement
- Annex IX X XI pathways
- Sampling and audits
- Certificate maintenance
- Change management control
Module 4: Performance Evaluation and Clinical Evidence
- PEP planning structure
- Scientific validity steps
- Analytical performance data
- Clinical performance studies
- GCP and ISO links
- Reporting and acceptance
Module 5: Technical Documentation and QMS Essentials
- Annex II structure
- Annex III PMS file
- Risk management files
- Usability and labeling sets
- Software file content
- Supplier control records
Module 6: Post Market Surveillance and Vigilance
- PMS and PMPF plans
- Trend reporting methods
- FSCA and incident flow
- Periodic safety updates
- Real world data sources
- Cybersecurity monitoring actions
Exam Domains
- IVDR Framework and Governance
- IVD Classification and Intended Use Strategy
- Conformity Assessment and Notified Body Interface
- Performance Evaluation and Evidence Generation
- Technical Documentation and QMS Integration
- Post Market Surveillance Vigilance and Reporting
Course Delivery
The course is delivered through a combination of lectures interactive discussions hands on workshops and project based learning facilitated by experts in the field of Certified IVD Compliance Specialist CIVDS. 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 IVD Compliance Specialist CIVDS.
Question Types
- Multiple Choice Questions MCQs
- Scenario based Questions
Passing Criteria
To pass the Certified IVD Compliance Specialist CIVDS Certification Training exam candidates must achieve a score of 70% or higher.
Ready to certify your IVDR readiness and strengthen cybersecurity in your IVD portfolio Enroll now to secure compliance accelerate approvals and elevate product trust.