Clinical Evaluation of Medical Devices (MB002)
690 €
Get familiar with the latest clinical evaluation requirements – quickly, clearly, and online!
Information
The training material is available interactively through an e-learning platform anytime and anywhere, allowing you to learn entirely at your own pace.
Your acquired knowledge will be assessed through online quizzes, and upon successful completion, you will receive a certificate confirming completion of the training.
✓ Author: Tímea Markóné Németh (Quality Assurance Expert, NoBoMed Zrt.)
✓ Access to the course material for 3 months from the date of purchase
✓ 60-page training material presenting the fundamentals of technical documentation
✓ Online tests to reinforce your knowledge
✓ Certificate documenting completed course modules and achieved results
Do you have questions about the course content? Simply send us an email at [email protected] and we will forward your question to the expert for a professional response.
Topics
- A few words about previous anomalies
- Attempts to resolve earlier issues
- Devices intended for medical purposes
- Depth and scope of clinical evaluation
- Clinical evaluation for multiple medical devices and their accessories
- Scope of manufacturer responsibility
- Mandatory designation of the PRRC
- Clinical evaluation planning
- Determination of the level of clinical evidence
- Continuous, objective, and detailed clinical evaluation
- Class IIb and Class III devices
- Legacy devices
- Relationship between clinical evaluation, GSPR, and risk management
- Anomalies during the MDD era
- Sources of clinical data
- Selection of the clinical evaluation pathway
- Performing clinical evaluation using non-clinical investigation methods
- When is a clinical investigation required?
- Literature route: objectives and sources of literature searches
- Collection of clinical data from Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities
- The 5 steps of clinical evaluation according to MEDDEV 2.7/1 rev. 4
- The 5 steps of clinical evaluation according to MDR Annex XIV
- Clinical Evaluation Plan (CEP) and content review requirements
- Evaluation of clinical data
- Processing and origin of clinical data obtained from literature searches
- Documentation of literature searches
- Verification of literature search sources, methods, and adequacy
- Processing and origin of clinical data obtained from clinical investigations
- Assessment of clinical data (relevant data)
- Requirements of MDR Annex XIV
- Requirements of MDCG 2020-5 guidance
- Technical, biological, and clinical characteristics
- Similarity considerations
- Questions related to modifications
- Claiming equivalence with a previous-generation device
- Verification of equivalence
- Clinical and non-clinical data
- References and cross-references
- Analyses
- Approval, date, and version number
- Content requirements according to MDCG 2020-6 and MEDDEV 2.7.1 Rev. 4
- Criteria applicable to the person performing the clinical evaluation
- Review and updating of the clinical evaluation
- Possible PMCF activities
- Planning PMCF activities
- Minimum content requirements of the PMCF Plan (PMCFP)
- Purpose of collecting additional clinical evidence
- Continuous updating and maintenance of current status
- Proactive manufacturer data collection
- PMCF report
