Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 19th Apr'24 to 29th Apr'24
Implementing the New Usability Engineering Standard -- IEC/TR 62366-2:2 Part 2: Guidance on Application
- Key parts of IEC 62366-1 and their implementation
- Written for easier to understand intent / implementation
- Part 2 focuses on “how” to implement (Part 1 on “what”)
- Closer ties to ISO 14971, Medical Device Risk Management
- Closer adherence to US FDA guidance; more harmonization
- Planning requirements and defined engineering process
- User interface considerations
- Key mobile apps considerations
Overview of the webinar
IEC has released a new explanation of its updated, medical device usability standard, IEC 62366-1:2015, with its “how” (to implement), IEC/TR 62366-2:2 Part 2: “Guidance on the application of usability engineering to medical devices.” This Part 2, together with Part 1, the “what”, 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 focus on the IEC standard’s Part 2. and it’s key requirements: “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. It will also reevaluate key portions of “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”, covered in a previous webinar.
Who should attend?
- Senior Management
- Middle Management
- QA/RA
- Operations
- Production
- Engineering
- Marketing
- Medical Device Consultants
Why should you attend?
The International Electro technical 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, and
- 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.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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 including 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 ptublished 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.