Clinical Evaluation & Post-Market Surveillance

May
27
Date: 27th May 2020 -
28th May 2020
Time: 08:30 - 17:00
Duration: 2 Days
Venue: Rochestown Park Hotel, Cork.
Address:
Event details:

Clinical Evaluation & Post-Market Surveillance

This course is a practical guide to assembling a clinical evaluation plan and report in accordance with the requirements of the Medical Device Regulation.  Additional requirements and the gap between the current Medical Device Directive and the regulation.  How to go from the stated objectives:

Safety
Efficacy
Risk v benefit
Literature review
Clinical investigations
Alternative therapies
Other claims made by the manufacturer
To conclusions which address each in turn
This course also explores the interactions between clinical evaluation and post-market surveillance and how they influence other aspects of the quality management system.
A practical guide to post-market surveillance
Planning PMCF
Sorting devices by risk
Implementing PMS/PMCF
Dealing with adverse events
Trending and reporting

Who should attend:
The content will have great value to individuals who are involved in any aspect of implementing or maintaining a clinical evaluation.
Quality Assurance Professionals
Quality Engineers
Research and Design Engineers
Clinicians
Manufacturing Engineers
Regulatory Professionals

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Delegate cancellation policy

Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.

Photography at events

There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.

Member
Per delegate: €499.00
(plus VAT)
Member
Book Now
Non Member
Per delegate: €650.00
(plus VAT)
Non Member
Book Now

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