How to protect yourself against development risks and precisely manage the Clinical Evaluation
As part of the conformity assessment, medical device manufacturers must conduct a clinical evaluation of their product’s safety and performance and prepare a clinical evaluation report.
A product may only be placed on the market if its risk-benefit ratio meets at least the requirements of the current state of the art.
A significant process risk arises when it becomes apparent only at the end of development that the chosen approach to clinical evaluation – such as one based on existing clinical data from the literature – is not feasible.
While the Medical Devices Regulation contains a number of requirements for conducting the clinical evaluation, and the documents in the MDCG series describe details and special cases, it remains unclear how manufacturers ensure that their clinical evaluation is consistent with the results of risk management and how and where they integrate the conduct of the clinical evaluation into their process landscape.
- Content
- Introduction to the regulatory framework
- Terminology and documents related to Clinical Evaluation
- Product characteristics
- Lifespan, Life Cycle, and Development Cycle
- Clinical Evaluation process flow
- Interaction with Literature Searches and Risk Management
- Phases of Clinical Evaluation
- Product Characteristics and Clinical Functions
- The Clinical Evaluation Plan
- Alignment with Risk Management
- Updating the Clinical Evaluation with PMCF results
- Your Benefits
In our course, you will learn:
- How to update the Clinical Evaluation with PMCF results
- How to structure the Clinical Evaluation in phases
- What “clinical functions” are, how to define them for your product, and how to use this definition in the Clinical Evaluation
- How product characteristics and risk classes influence the Clinical Evaluation
- How the state of the art influences the Clinical Evaluation
- How to use the product requirements for the Clinical Evaluation
- How to use the results of validation and verification to determine the scope of the Clinical Evaluation
- How to integrate the Clinical Evaluation and Risk Management
- How the results of the Clinical Evaluation determine the PMCF
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Authors of clinical evaluations
- Clinical Affairs Managers,
- Regulatory Affairs Managers,
- Developers,
- Product Managers,
- Risk Managers,
- Employees of Notified Bodies,
- Employees of regulatory authorities
