Survey: 75% MedTech Pros Unprepared for an Unannounced FDA or Notified Body Audit
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
Tag Archives: engineering
Making Way for Probability in Human Factors (Part I)
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
Reliable Real-time Software for Medical Devices
For reliable systems, we need a different mindset.
Growth in Medical Devices Spurs Recruitment Challenges
In addition, in workforce optimization, retention plays an equally important role as recruitment.
HFE Practice Models: How Manufacturers Establish and Maintain HFE Competency
Manufacturers can rely upon internal human factors engineers and/or external consultants to apply HFE effectively during device development.
The Value of a Sound Human Factors Plan
Why you can’t afford to overlook this important part of product development.
Top Three Disconnects in Product Development
The unpredictability of the process can make it difficult to stay on track throughout every phase.
Human Factors, Combination Products Focus of Latest FDA Guidances
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
Considerations When Using Postmarket Data in Risk Management
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
Obamacare and Great User Expectations Hit Device Design
Don’t ignore the changing medtech landscape; it will continue to affect product design and manufacturing. A discussion with Kenneth Fine about design challenges.
