PPT Slide
AN INTENSIVE PRACTICAL 1/2 DAY COURSE
Paul Shane Bennetts is the Managing Director of M.Devices Group. He has previously worked Pharmaceuticals and more recently with Medical Devices & Drug Delivery Devices. An auditor in Quality & Regulatory Systems for Europe & the USA.
Benard Tremaine is a Technical Specialist in 93/42/EEC general Strategies, IRCA registered Lead Auditor (A007435) & an Active Medical Devices Specialist, covering:Electrical Safety, Vital Signs Monitoring. Life Support Equipment, Catheterisation, Laboratory Catheterisation, Quality Assurance, Regulatory Assurance, Stress Test Systems
1.15pm Registration and Coffee
1.30pm - Structure of the MDD
Speaker: Paul Shane Bennetts
- Recitals, Articles & Annexes
- Intended Use & Classification
- Conformity Routes
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2.15 pm - Technical Documentation & Essential Requirements
Speaker: Bernard Tremaine
- Placing the device on the Market - Who is a manufacturer ?
- Understanding the Essential Requirements
- Instructions for Use & Manufacturer’s Claims
- The Role of the Notified Body
3.30 pm - A Practical Session in Classification
Speaker: Paul Shane Bennetts
- The Elements of Classification
- A Practical Application
4.15pm Declaration of Conformity
Speaker Bernard Tremaine
- Understanding the Declaration of Conformity
- Preparing a Declaration o f Conformity
4.45pm Questions & Certificates
Bernard Tremaine & Paul Shane Bennetts
- Award of Training Certificates
5.00pm - Close of Training Day
What others say about MDG’s training Courses -
‘The practical applications really helped in understanding the Medical Devices Directive’
‘The CE Mark is no longer a mystery’
Remember - Staff Attendance & involvement on this Training Course should be entered on each delegates training records
Literature: Each Delegate will receive a copy of the Medical Devices Directive.