AI for Medical Device Design Controls

This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development under Design Control, ISO 13485 7.3. Product AI requirements, abd using AI to assist in Design Control documentation will also be discussed.

It should be an important part of a company's IP (Intellectual Property). Follow the 10 required steps (bothUS FDA and EU MDR) to design contol compliance in R&D and company-wide. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" and "scope creep" in a new project. It can contribute to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Why should you Attend

The FDA expects companies to manage the regulatory requirements of design control, and the unique requirements of AI with consideration of all applicable standards. How can the FDA's Design Control requirements, 21 CFR 820 / ISO 13485 7.3 actually facilitate this? The EU MDR and their notified bodies are no different.

How can this be done from a project's inception? How can a Project Leader ensure critical elements are not ommitted until late in the project when disaster looms? How does this translate into better, safer product in the field. Growing high-profile field problems indicate that much design control is prefunctory, poor or non-existant - and it's worse for the AI component. Buy up-front time for proper project planning. Simple tools / techniques are not rocket-science, but require the implementation of formal methods with documented and defensible rationale. Use these tools to bring predictability to your company's product development process.

Areas Covered in the Session

Meet key design control requirements of the CGMPs/ISO
The 10 Key Elements of Design Control
21 CFR 820 / ISO 13485 7.3, EU MDR, CE-Marking
Risk Management (ISO 14971)
Use Engineering (IEC 62366)
Suggested SOP Format
A Suggested Design Control Project Management Template
One Major, But Often Neglected, Use

Who Will Benefit

This webinar will provide valuable assistance to all regulated companies to ensure compliance to the design control requirements of ISO 13485 7.3 - under US CGMP and EU MDR/CE-marking compliance, facilitated by compliant AI. It will discuss and provide examples of the 10 key design control milestones and associated tasks and provide a major example for immediate use. This applies to companies in the Medical Device, and combination products fields. The employees who will benefit include:

Senior Management
Regulatory Affairs
Quality Assurance / QAE
Production
R&D and Engineering
All Personnel Tasked with any new or Changed Device Development Responsibilities, and those who soon hope to be

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.