WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,

Florida,

United States,

ZIP: 33021

Phone: 347 282-5400

DESCRIPTION

The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. ISO 13485:2020 has almost identical requirements. The company is held responsible for deciding when to start and the specific documentation to meet the 10 requirements.

Areas Covered In the Seminar

• FDA Device Clearance / Changes in Direction
• Current Design Control Requirements
• How to Define the "Start" Date and Its Significance
• The 10 Design Control Elements and Their Implementation and Documentation
• "Retroactive" Design Control – Not Desirable but Doable
• The Business Case for Design Control

Who will benefit

• Corporate Management
• QA
• RA
• R&D
• Engineering
• Production
• Marketing
• Other Consultants
• Personnel in FDA- and EU MDD / MDR-regulated industries, Devices, Combination Products

Instructor Profile
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 35 years experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.