Industry Roundup: Medical Device Technology Advances in the Wake of Cybersecurity Concerns
Despite ongoing concerns about cybersecurity, the medical device landscape has seen some amazing advances even just this year.
5 Ways to Build a Safety-First Culture
November 26, 2019 in Functional Safety Medical Devices, Automotive, Aerospace and Defense /by Jama SoftwareToday’s move-fast-get-it-to-market-yesterday product development culture puts a lot of pressure on companies to innovate quickly, but creating a safety-first culture can save you from product recalls and failure.
How the FDA’s New Safety and Performance Based Pathway Could Affect Medical Device Development
November 21, 2019 in Compliance & Regulation Medical Devices /by Jama SoftwareThe 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.
5 Updates Pending to the FDA’s Cybersecurity for Premarket Submissions
October 31, 2019 in Compliance & Regulation Medical Devices /by VelentiumIn this post, we offer insight into anticipated changes coming in the official update.
10 Amazing Product Development Innovations of the 2010s
October 17, 2019 in Product Development & Management Medical Devices, Consumer Electronics, Automotive, Aerospace and Defense /by Amy DavisThe 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
October 10, 2019 in Customer Spotlight Medical Devices /by Jama SoftwareSee 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
September 10, 2019 in Product Development & Management Medical Devices /by Kevin SmithThe 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
August 1, 2019 in Customer Spotlight Medical Devices /by Jama SoftwareGrifols increases efficiency and cuts costs by optimizing their requirements and risk management process with Jama Connect.
Agile Methodology for Medical Devices
July 25, 2019 in Product Development & Management Medical Devices /by Jason SwobodaThe 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
July 23, 2019 in Risk Management Medical Devices, Financial Services and Insurance, Automotive, Aerospace and Defense /by Jama SoftwareYou’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.