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How to Establish and Maintain Device Design and Development (Design Control)

January 3, 2024 (10:00 AM PST | 01:00 PM EST)
Virtual Training Through WebEx

Sponsored by ComplianceOnline

Click Here to register $199.00

Click Here to register $399.00

This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new or heavily changed product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Also regulatory compliance proof of "progress against plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property).


Facilitating the device design and development process with proper use of design control.

Follow the 10 required steps (bothUS FDA and EU MDR) to design contol compliance in R&D. How are the requirements of product risk management and human factors / use engineering incorporated and when. Use these requirement to reduce scheduling uncertainty, incomplete projects when time is running out, increased product liability, while assisting in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Why Should You Attend:

The medical device design and development process is the start of new and major changed product development, but also the source of serious "unintended consequences" having negative outcomes for users in the field. Design control is one key way in which the US FDA (and the EU) expects companies to manage the regulatory requirements of design and/or change control.

How can the FDA's Design Control requirements, 21 CFR 820.30, actually facilitate this? 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?

Where is ISO 14971 Risk Management and IEC 62366-1 Use Engineering mandated - and how? Design control requires the implementation of 10 formal methods with documented, and defensible rationale. Use these tools to bring predictability to your company's product development process. Further use them to improve your company's capture of IP (intellectual property).

Areas Covered in the Webinar:

  • Meet key design control requirements of the CGMPs/ISO
  • The 10 Key Elements of Design Control
  • 21 CFR 820.30, EU MDR, and ISO 13485 7.3
  • Risk Management (ISO 14971)
  • Use Engineering (IEC 62366-1 +)
  • SOP Basics
  • A Suggested Design Control Project Management Template
  • US FDA and EU MDR documentation requirements

Instructor Profile:

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).