Boston Professional Events List


Design Control, Device Risk Management, and Usability Engineering, Under US...


Date
Nov 15, 2017 - 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 13485:2016 has almost identical requirements. The company is held responsible for deciding when to start and the specific documentation to meet the 10 requirements. This can be a powerful tool in reducing "time to market" / "fast cycle" product development. 

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 ControlAreas 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
     



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.
     


Event Categories
Keywords: Education




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