Training Course Syllabus:

Navigating through the Medical Device Design Control Minefield Webinar

This webinar will explore how a manufacturer must develop effective medical device design controls to avoid compliance risks.

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.

Knowing how the FDA both views and examines design controls is crucial in achieving compliance throughout the life of the medical devices you manufacture. 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 in supporting 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.

Why Should you Attend:

The number of medical device recalls over the past several years has almost doubled each year indicating that the FDA is increasingly looking at the medical device industry in general and how products are designed and managed in particular. Manufacturers are at significant compliance risk when their design control processes are flawed and are not carefully designed. Compliance risk has significant health and safety implications that medical device companies today can simply not ignore.

Objectives of the Presentation:

On completion of this training participants will be able to:

• Describe the regulatory guidance concerning design controls


• Explain each step of the design control process


• Define the iterative nature of the design control process and how


• Define validation and verification


• Explain the importance of and differences between design inputs and outputs


• Explain how validation and verification is accomplished


• What is the design control plan


• Explain where in the process design verification and validation occurs


• Explain the Life Cycle process and how it relates to design controls in general


• Explain the impact and importance of documentation upon design controls


• Explain the importance of design control reviews and how those reviews are executed


• Explain the pitfalls of software development and how the software development process is reflected in design controls


• Explain how compound products are addressed by design controls – which regulations apply


• Please mention below the Areas will be covered during the Session: (Should have more than 6 bullet points)


• 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

Seminar Summary:

Learn how to develop medical device design controls in compliance with the federal regulations, learn about CFR 21 Part 820. (see full course description)

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