MMD-104 EU Medical Device Clinical Evaluation
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Details
A clinical evaluation needs to be conducted on each medical device type or family by the manufacturer in order to allow the medical device to be legally placed in certain regulated markets. This is a mandatory prerequisite
regardless of the risk classification. The collation of clinical data is a key aspect of the EU CE Marking conformity assessment process. It allows the manufacturer to substantiate safety, performance and benefit/risk assessment claims made.
Revision 4 of the MEDDEV guidance document 2.7/1 was released on 1st July 2016. This new version includes new requirements and is aligned with the EU Medical Device Regulations and also covers requirements specifically
for Post-Market Surveillance (PMS), and Post-Market Clinical Follow-Up (PMCF).
Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor and technical file reviewer, has nearly 3 decades of assessment, training and quality assurance as well as management system
development experience. Participants will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance.
Outline
- Considerations in determining as to whether clinical trials/ investigation are required for a particular medical device
- Clinical Evaluation requirements as specified in MEDDEV 2.7/1 rev.4
- GHTF/IMDRF guidance on Clinical Evaluation
- Pre and Post Review Risk Evaluation
- Aspects of design and intended use equivalence
- Clinical Literature reviews
- Notified Body expectations on Clinical Evaluation documentation submissions
- Clinical data in meeting the General Principles of Safety & Performance
- Post Market Clinical Follow-ups and residual clinical risks
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Ampro believes that the key to a successful and rewarding career is continuous professional development. We have a flexible approach to your training needs with regardless of whatever your requirements, we promise you a high level of service with packages that meet the needs of your business.
As a forward thinking company we deliver training at all levels, thereby supporting your company at every stage of its development. Courses can be delivered onsite at a location of your choice, costs dependent upon location and numbers, or at hotel.
Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
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