5 Updates Pending to the FDA’s Cybersecurity for Premarket Submissions
In this post, we offer insight into anticipated changes coming in the official update.
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In this post, we offer insight into anticipated changes coming in the official update.
The next generation of product development and disruptive technologies that used to remain in isolated industries are now crossing boundaries.
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.
Grifols increases efficiency and cuts costs by optimizing their requirements and risk management process with Jama Connect.
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.
You’ll gain more confidence that your recently-released products avoid recalls, fines, or worse if you perform failure mode and effects analysis (FMEA) as part of your risk management.
Poorly-written requirements can cause a lot of problems in software development, and sometimes the symptoms can be traced back to requirements gathering.
Devices recalled nationwide are typically taken to task for usability issues that could have been prevented with proper usability testing throughout a product’s development lifecycle.
While connected medical devices provide opportunities for instantaneous results and early intervention, they’re also more vulnerable to cyberattacks.