The New Usability Engineering Standard in IEC 62366-1:2015- Application and IEC/TR 62366-2:2016

IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 —  Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Its 9 Stages provide a repeatable process for performing UE and documenting the process and results in a UE File. These address 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 focus on the two parts of the standard and it’s key requirements and application to medical devices.

Why You Should Attend:

The International Electrotechnical Commission has recently published this updated standard, in two parts.  It addresses an on-going concern by regulatory agencies in both the US and EU — human factors engineering /    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.  This provides major benefits to company and user, such as:

Specific beneficial outcomes of applying human factors/usability engineering to medical devices include:

• Easier-to-use devices
• Safer connections between device components and accessories (e.g., power cords, leads, tubing, cartridges)
• Easier-to-read controls and displays
• Better user understanding of the device’s status and operation
• Better user understanding of a patient’s current medical condition
• More effective alarm signals
• Easier device maintenance and repair
• Reduced user reliance on user manuals
• Reduced need for user training and retraining
• Reduced risk of use error
• Reduced risk of adverse events
• Reduced risk of product recalls

Employment of these principles is carefully looked for and reviewed by regulatory agencies in device submissions, especially as products and procedures become ever more complex.

Areas Covered in the Session : 

• Key parts of IEC 62366-1
• Written for easier to understand intent / implementation
• Part 1 focuses on “what”, Part 2 on “how”
• Closer ties to ISO 14971, Medical Device Risk Management
• Closer adherence to US FDA guidance; more harmonization
• Planning requirements
• Defined engineering process
• User interface considerations

Who Should Attend:

• Senior Management
• Middle Management
• QA/RA
• Operations
• Production
• Engineering
• Marketing
• Medical Device Consultants

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.