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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10 Amazing Product Development Innovations of the 2010s
The next generation of product development and disruptive technologies that used to remain in isolated industries are now crossing boundaries.
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.
A Developing Story: Grifols Reduces Medical Device Development by 80 Hours Using Jama Connect
Grifols increases efficiency and cuts costs by optimizing their requirements and risk management process with Jama Connect.
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.
Answers to Your Questions About Risk Management and FMEA
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.
Requirements Gathering Best Practices for Software Development
Poorly-written requirements can cause a lot of problems in software development, and sometimes the symptoms can be traced back to requirements gathering.
Reducing Medical Device Risk with Usability Testing: The Why, the How, and the Who
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.
The Rise of Connected Medical Devices and the Importance of Requirements Traceability
While connected medical devices provide opportunities for instantaneous results and early intervention, they’re also more vulnerable to cyberattacks.