Design Controls for Medical Devices under a Quality Management System
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Speaker : DON HURD
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When : Tuesday, July 09, 2024
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Time : 01 : 00 PM EST
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Don Hurd has over 40 years of experience in supporting the development of applications of or containing software in regulated industries, the last 20 in medical devices.
- Established company QMS and led company to 13485 registration (12+ years); dual registration to 9001 (8+ years)
- Successfully led numerous companies through standing up a new QMS, leading to ISO 13485 certification
Serving as ‘Quality Manager’ and ‘Management Representative’ for several companies.
Design controls are a discipline that everyone in the medical device industry have to come to grips with. It encompasses systems engineering, risk management, mechanical/electrical/software design, usability engineering, and testing (verification and validation). The documentation of these activities is critical to both develop a good product but also to ensure a smooth regulatory clearance.
Areas Covered
- Background
- Design Inputs
- Design Outputs
- Influences from Risk Management
- Influences from Usability Engineering
- Influences from Software Engineering
- Design Reviews
- Verification and Validation
- Design Change
- Design Transfer
Who Should Attend
- Management
- Project Managers
- Quality Engineers
- Purchasing
- Postmarket support
Why Should You Attend
Doing “good” work is not sufficient to get a medical device through the regulatory gauntlet. You must comply with applicable regulations, under which, design controls are required elements. Some of the concepts can be challenging. Further, there are a number of other standards that drive how design controls are implemented. Without understanding these, design controls will be incomplete.
Topic Background
Design Controls are required elements under both FDA regulations and under ISO 13485 (the international standard for medical device quality systems). Some of the concepts can be challenging for those getting into the field.
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$199.00
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