Course description
Clinical Evaluation of Medical Devices
This Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.
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Suitability - Who should attend?
This course is suitable for
- Students of the TOPRA MSc programme
- participants from the regulatory affairs industry who wish to develop their knowledge of the requirements for the clinical evaluation of medical devices
- participants from allied industries who wish to have a comprehensive understanding of the subject
Outcome / Qualification etc.
Benefits to participants
- Demonstrate a systematic understanding and critical awareness of the regulatory requirements, directives and associated documentation relating to the clinical evaluation
- Critically evaluate the methodology an conduct of clinical research
- Appraise the factors that influence the quality of clinical evaluation
- Be able to critically evaluate existing literature and assess the need for clinical evaluation
- Demonstrate the ability to critically analyse the legal documentation relating to clinical evaluation of devices
- Deal with complex issues both systematically and creatively and make sound judgements in the absence of complete data and communicate conclusions clearly to non-specialist audiences
- Critically appraise and evaluate communications from regulatory bodies and stakeholders relating to the conduct of clinical research
Training Course Content
The Masterclass will cover:
- Increased Manufacturers obligations
- ISO14155 and the implication of MDR
- Clinical evaluations and investigations
- Post market clinical obligations and studies
- The device life-cycle
- Global strategy requirements
- Pre-clinical evaluation of medical devices
- Medical Device Regulation 2017/745
- Increasing obligations for manufacturers: impact on industry (tracing the changes 2.7/1 rev.3 to rev.4 to MDR
Expenses
The full tuition price for students is 1500 GBP. The price for participants is 1700 GBP
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