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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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.
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.
See how medical device development company Össur uses Jama Connect to comply with with international medical device standards like ISO 13485 and ISO 14971.
The landscape of medical device development is shifting rapidly. Here are the three biggest challenges facing medical device development.
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.