Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices

690 €

Get familiar with the latest clinical evaluation requirements – quickly, clearly, and online!

Category:

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 info@noboversum.hu and we will forward your question to the expert for a professional response.

Topics

Clinical Evaluation and the Medical Device
  • A few words about previous anomalies
  • Attempts to resolve earlier issues
Subject of Clinical Evaluation
  • 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
Collection of Clinical Data
  • 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
Evaluation of Clinical Data
  • 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 of Clinical Data and Origin of 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)
Device Equivalence
  • 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
Formal and Content Requirements of the Clinical Evaluation Report (CER)
  • 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
Inputs from Clinical Evaluation to Post-Market Clinical Follow-up (PMCF)
  • 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

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