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.
The FDA, since 1990, 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 results 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 much open to interpretation and assumption on the part of manufacturers, which also leads to potential compliance issues throughout the design process, along the supply chain, and for the total life of the product.
Knowing how the FDA 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 is consistently uncovered by the FDA during inspections and examinations, is concerned with the design control process that has been designed and applied, and the documentation that is 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 section 820.30 and section 820.40. These sections of the regulation are extremely complex and difficult to apply particularly for organizations that are new to the medical device field. You must understand the design control process and how your process must be mapped to the FDA’s view in order to meet your compliance obligations. Join this session, where expert speaker Charles H. Paul 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 your organization.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence....
More Events By The Speaker