Medical Device Usability and Human factors (EN 62366). Impact of the new European Medical Device Regulation

2- Day Training for RA/QA Professionals of the MD Industry

Medical Device Usability and Human factors (EN 62366). Impact of the new European Medical Device Regulation

California | September 22-24, 2019 | Register Now!

About the training

The ability for a human to interact easily and relatively error-free with a system, product or procedure. Manufacturers are increasingly expected to provide a safe product that the user understands thus errors are minimized. Terms such as “user-friendly” and “intuitive” have emerged as descriptors of usability which translate to subjective attributes regarding whether a system or device works and acts in the way the user expects, therefore avoiding frustration and annoyance in carrying out an intended action.

As medical devices become increasingly diverse in their capabilities and the environments in which they are used becomes busier, with new distractions and requirements for specialized training, the potential for use error also increases.

Knowing that the Medical Device Regulation will require possibly more evidence of use-safety, usability and human factors engineering – because there are more clauses covering this area; it is useful to know what to do when you have existing medical devices, software and systems in the market.

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Medical Device Usability and Human Factors (EN 62366) standard, and the impact of the new EU MDR.

During this 2- day course, you will learn:

• Overview of basic concepts from the key Usability standard IEC 62366-1:2015, and how you should be using this to improve your products, reducing risk.
• The main differences between IEC 62366-1:2015 and EN 62366:2008
• The role of Risk Management (ISO 14971:2007) in the Usability Engineering Process (IEC 62366-1:2015)
• The importance of the Usability and Medical Device Quality Management System (EN ISO 13485:2016)
• The Impact of the new EU MDR on Medical Device Usability and Human Factors (EN 62366)

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Keywords:  European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Electrical Safety (IEC 60601-1), Medical Device Electrical Safety, ISO 14971:2007, IEC 62366-1:2015)

WHO SHOULD ATTEND

• Medical Device Manufacturers: Senior Management, Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
• Internal and external Auditors
• Importers
• Distributors

REQUIRED LEVEL

• Good knowledge and effective practice of the Medical Device Usability and Human factors (EN 62366). Impact of the new European Medical Device Regulation.

The number of participants is maximized to fifteen to provide a stimulating and practical working environment.

EDUCATIONAL RESOURCES

• Presentations
• Practical working sessions
• Course evaluation
• Lunch meeting with the trainer (Lead Auditor and Technical File Assessor for high risk devices)

LEARNING OBJECTIVES

• Understand EN 62366 Usability engineering process
• Understand Notified Body Expectations
• Understand main differences between IEC 62366-1:2015 and EN 62366:2008
• Understand the role of Risk Management (ISO 14971:2007) in the Usability Engineering Process (IEC 62366-1:2015)
• Understand the importance of the Usability and Medical Device Quality Management System (EN ISO 13485:2016)

DAY 1 & 2

8:30 am to 9:00 am - Breakfast

9:00 am – 12:15 pm:

• Introduction to Usability Standard.
• Scope and Definitions
• Usability Standard Requirements
• Actors and Responsibilities
• Quality Management System requirements

12:15 pm – 1:00 pm - Lunch

1:00 pm – 5:00 pm:

• Practical working sessions
• Group workshop
• Course Evaluation
• Summary and Discussion with the trainer

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About the trainer

Sara Jafari, PhD AIMD Design Dossier Evaluator and Medical Device Certification Project Manager Dr. Sara Jafari is an AIMD Design Dossier Evaluator and Medical Device Certification Project Manager at GMED North America. She is a biomedical engineer and received her PhD in medical imaging from Pierre and Marie Curie University (Paris, France). Sara has extensive experiences in development of electro-medical device testing programs, including safety testing (IEC 60601-1 family of standards), evaluation of software (IEC 62304) and review of usability studies (IEC 62366-1) in addition to developing, testing and optimizing medical imaging sequences. Dr. Jafari is working as an active implantable medical device design dossier evaluator (EU directive and regulations) and certification project manager specialized in active medical devices at GMED North America.