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Subscribe NewsletterElements of a Medical Device Requirement Specification
Product Id
:
600174
Overview: In order to start the ball rolling for new medical device and after the Marketing folks have provided R&D with their input, the Requirement Specification combines these processes.
In the medical device industry starting with a complete and properly documented Medical Device Requirement Specification is essential for all of the processes which follow. This document lays the groundwork for the second tier specifications, regulatory requirements, and risk management process while at the same time providing an organization with the new device's "Intended Use" statement from which the development process and the device itself evolves. This webinar session will provide the participant with a descriptive outline of what is required in a clear and concise product requirement specification.
In the medical device industry starting with a complete and properly documented Medical Device Requirement Specification is essential for all of the processes which follow. This document lays the groundwork for the second tier specifications, regulatory requirements, and risk management process while at the same time providing an organization with the new device's "Intended Use" statement from which the development process and the device itself evolves. This webinar session will provide the participant with a descriptive outline of what is required in a clear and concise product requirement specification.
Areas Covered in the Session: Elements of a Medical Device Requirement Specification including:
- Definition of Disciplines Involved in Development of the Plan
- Regulatory Elements
- Quality Elements
- Consensus Standards
- Indications for Use
Who Will Benefit:
- Design Engineers
- Quality Assurance Personnel
- Program Managers
- Regulatory Personnel
- Executive Management
- Marketing Managers