Accelerate Medical Device Development with Modern Requirements Management
3 improvement strategies to insert risk control as a crucial part of the medical device development framework to comply with ISO standards and EU MDR.
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How the FDA’s New Safety and Performance Based Pathway Could Affect Medical Device Development
The US Food and Drug Administration (FDA) has issued new guidance that expands the Abbreviated 510(k) Program for medical device development and premarket notification submissions.
A Developing Story: Jama Connect Helps Össur Improve the Mobility of Millions
See how medical device development company Össur uses Jama Connect to comply with with international medical device standards like ISO 13485 and ISO 14971.
How to Overcome Three of the Biggest Challenges in Medical Device Development
The landscape of medical device development is shifting rapidly. Here are the three biggest challenges facing medical device development.
Agile Methodology for Medical Devices
The Agile methodology offers medical device developers options that anticipate and prevent the bottlenecking and potential crisis points to which static development models are normally vulnerable.
A Developing Story: Elucent Medical Began Developing Surgical Tools with Jama Connect™ in Less Than a Week
“The biggest benefit for us is the efficiency in completing and gaining agreement on requirements and testing procedures.”
Designing a Better Usability Engineering Plan for Medical Device Product Development
Approximately 400,000 hospitalized patients each year experience some type of preventable harm related to medical devices. The cause could be medical equipment flaws, design mishandling or user error malfunctions – all of which can be prevented with a robust usability engineering plan.