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

Hollywood,

FL,

US,

ZIP: 33021

Phone: 347 282-5400

IEC has released a new medical device usability standard, IEC 62366-1:2021 --  Part 1: “Application of the new Usability Engineering Standard to Medical Devices”, and its companion “IEC/TR 62366-2:2021 -- Part 2: Guidance on the application of usability engineering to medical devices” .  These addresses an on-going concern by regulatory agencies in both the US and EU, human factors engineering, or it’s synonym, usability engineering.  Usability can be defined as “the ability for a human to interact easily and relatively error-free with a system, product or procedure.” The FDA views human factors engineering as mandated to reduce user error and make medical products use as close to intuitive as possible, especially since 2000. In one of their guidance documents on the subject, it states: “CDRH considers human factors testing a valuable component of product development for medical devices.”   This webinar will address the requirements of the IEC standard and its 9 stages of documentation, as well as the non-regulatory tutorial / guidance of its companion,  “IEC/TR 62366-2.
 

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.  

 

Areas Covered

 

•     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
•   R&D
•   Engineering
•   Software engineers
•   Manufacturing / Operations
•   Marketing
•   Purchasing
•   Consultants
•   All others tasked with product development, acquisition and production

Speaker Profile

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.