professional development courses


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Human Factors Excellence for Medical Device Design

At a time when medical device companies are looking to achieve validation and comply with updating regulations from the FDA, the largest hurtle is creating medical device products than can be easily and successfully used by human operators. The goals should always be bent toward the minimization of user-related hazards and risks so their devices can be successfully used safely and effectively. The purpose of this event is to help medical device companies develop or improve their engineering methods in developing a safer medical devices, through usability testing and risk mitigation. As the number of user for medical devices grows, those devices should be put through the proper tests to make sure they are as safe as they can be for the end user.

Turning 'Theory' into 'Practice'?

We have created a program that will introduce you to the skills, tools and the methodologies essential to the successful planning and controlling of projects. Of particular focus will be the development of your own people management and interpersonal skills required to deliver performance on projects at all levels. The course is driven by practical experience and your needs, giving you the opportunity to immediately apply your new understandings and skills to your own projects.

Who should attend?

Principal Engineers, Engineering Advisors, Senior Research Engineers Human Factors/Human Factors Engineering User Experience Design/User Design Usability/User Experience/User Interface/UX/UI Industrial Design/Design Controls Engineer Product Development Research & Development (R&D) Engineer Device Engineering Quality/Quality Control/Quality Assurance/Quality Engineer Regulatory Affairs

Key areas to be covered in the programme and documentation

Day One

  • Preparing an HFE Plan: Know what is needed and when
  • Executing Early Steps: Setting yourself up for success
  • Ethnographic Methods: How to get rich data
  • Data Dump: How to make sense of your learnings

Day Two

  • Moderating Studies: How to lead study activities for best results
  • Study Outputs: Aligning HFE with risk management
  • Product Development and Innovation: Putting all the data to good use
  • Verification and Validation: Let's get regulatory approval!


Benefits to you

Learn how to develop your medical products to be safer, and easier to use. Develop design engineering methods to create safer interactions between users and device interfaces. Discuss "ease-of-use," methods such as easier interaction interfaces, simplifying maintenance and repair, and reducing the need for user training and a reliance on user manuals. Reduce the risk of adverse effects through the use of the product, and reduce the risk of product recalls. Improve the user's understanding of the device's status and operation, and increase their likelihood of a positive adoption experience. Better understand the user's specific medical condition the device is made for.

Companies already benefiting include:

3M, Bayer, Biogen, Edwards Lifesciences, Dexcom, Medtronic, Pfizer, Nordson Medical, Senseonics, Stryker

Duration of Course

November 12 - 13 Day Course

Course details

Looking to train larger teams in this subject?

 


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Further information

UK Enquiries: +44 (0) 203 002 3057
or dzingim@marcusevansuk.com

Non-UK Enquiries: +420 (0)2 5570 7246
or training@marcusevanscz.com

North American Enquiries: +1 312 540 3000 X6714 or emilyj@marcusevansch.com




Testimonials

"This course will allow my company to develop its existing strategies to a much greater and hopefully profitable level."

Managing Director, Tarmac