Two Day Pre-Conference Short Course
16-17 March 2010, 9:00am – 5:00pm
Biopolis Singapore, The Matrix,
Breakthrough on Level 4, 30 Biopolis Street Singapore
Design Control for Medical Devices
Led by Mr Steve Marshall, AIPM, CEO, Perficio Product Development
and Dr John McCarthy, VP Manufacturing and Operations, Quality Manager,
GENERA BIOSYSTEMS, Australia
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Course Overview
Design Control for Medical Devices is designed to provide an intensive and in-depth two-day training covering the elements of design control with an emphasis on imparting detailed knowledge of the requirements of ISO 13485:2003 – Medical Devices – Quality Management Systems – Requirements for regulatory purposes, Section 7.3 Design and Development. Upon completing this course, participants will be able to understand design and development planning, design input, design output, design review and design verification requirements of the standard and shall have a method of implementation of each of these provisions, allowing integration within an overarching project management infrastructure.
Course Outline for Two Days
• Overview of both the US and EU regulatory systems for medical devices
• Design and Development Planning
• Design Inputs
• Design Outputs
• Design and Development Review
• Risk Management
• Risk Analysis
• Risk Analysis (continued)
• Design Verification
• Design Validation
• Change Control
• Regulatory Submission Requirements
About The Course Leader
Mr Marshall is the Chief Executive Officer of Perficio Product Development. He has over 30 years of extensive, professional experience in the medical device and telecommunications industries. He has a recognised track record in effective and successful management of numerous product and
system development projects, including implantable medical devices, e-commerce terminals, SCADA
system development and cryptology based secure data communicated equipment.
Who Should Attend
• Engineers and scientists involved in the development of medical devices.
• Project leaders and Line and Operations Managers who control or influence the development of medical devices.
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