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Boston Professional Events List
Live Webinar Use / Human Factors Engineering to Satisfy the New IEC 62366-1, -2
Link to Website
Ticket Price: $179 One Dial-in One Attendee | Corporate Live Recorded $279 One Dial In - Max 10 attendees |Group $399 Multiple locations upto 5 dial in | Recorded $249
Why should you attend
This webinar will answer basic questions device manufacturers, start-ups, investors and other stakeholders have as to the basic medical device development process incorporating Human Factors / Usability Engineering and its documentation / files, in the U.S. and EU. Meeting regulatory requirements. The integration of the 9 Stages of Use Engineering as well as Product Risk Management (User / Patient) into the Design Control, Design and Development Planning, process, and documentation additions to the DHF / D&DF will be discussed.
• Key parts of IEC 62366-1, and its implementation
• Part 1, “what”, and Part 2, “how”
• Ties to ISO 14971, Medical Device Risk Management
• Closer adherence to US FDA guidance; more harmonization
• Planning requirements
• The 9-stage engineering process
• Use[r] interface considerations
• Scenarios, Formative and Summative evaluations
• The Usability Engineering File
• Putting it all together – the DHF / D&DF / Technical Documentation.
Who will Benefit
• Senior management
• QA / QAE / RA
• Software engineers
• Manufacturing / Operations
• All others tasked with product development, acquisition and production
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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.
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