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Design Control, Device Risk Management, and Usability Engineering, Under US...
Date
Nov 16, 2021 - 01:00 PM
Organizer
conference Manager
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,
Hollywood,
Florida,
United States,
ZIP: 33021
Phone: 347 282-5400
Ticket Price: $179 One Dial-in One Attendee, $395 Group, $249 Recorded, $295 CD/DVD
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
- Corporate Management
- QA
- RA
- R&D
- Engineering
- Production
- Marketing
- Other Consultants
- Personnel in FDA- and EU MDD / MDR-regulated industries, Devices, Combination Products
Speaker Details
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.
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.
Event Categories
Keywords: Educationa