Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed.
Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Quality System regulation found in Sec. 820.30 and Sec. 820.40. These sections of the regulation are extremely complex and difficult to apply particularly for companies that are new to the medical device field. This webinar will explore how design controls should be designed to meet both the spirit and intent of the regulation and the needs of both the medical device itself and the organization.
Why You Should Attend:
The FDA has required that manufacturers of medical devices adhere to a specified process methodology for the design, development, and lifecycle management of the products manufactured. It is expected (and is subject to regulatory scrutiny) that the application of that methodology result in a specific iterative design process that meets the needs of the company, the device that is being produced, and maps to the FDA’s design control process guidance. The regulation leaves the door open to much interpretation and assumption on the part of manufacturers which also opens the door to potential compliance issues throughout the design process, along the supply chain, and for the total life of the product.
Understanding the design control process and how your process must be mapped to the FDA’s view is essential to meeting your compliance obligations.
- CFR 21 Part 820 Quality System regulation found in Sec. 820.30 and Sec. 820.40
- Design control process steps
- Designing your design control process – the design control planning process
- Mapping your design control process to the FDA’s interpretation of design controls
- Design inputs and outputs
- Verification process
- Validation process
- Importance of process step documentation
- Review processes
- Life cycle management
- Compound products
- Medical device applications
- Medical Device Design Engineers
- Device Development Teams
- Manufacturing Departments
- Quality Departments
- Research and Development Departments
- Plant Managers and Supervisors
- Regulatory Affairs Departments
- Compliance Departments