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.
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The Importance of ISO 26262 in Automotive Development
When teams aren’t set up with the right tools, implementation strategies, and best practices, compliance with ISO 26262 becomes an afterthought — and an auditing nightmare.
5 Ways to Build a Safety-First Culture
Today’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
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.
Streamlining Requirements Reviews: Best Practices for Moderators, Reviewers, and Approvers
Formal and informal reviews may necessitate different things from each of these roles, but we’ve compiled a list of best practices by role to make reviews go quickly and smoothly.
Building a Culture of Innovation: How a Good Product Design Critique Process Fosters Team Collaboration
As more companies pull design functions in-house, knowing how to properly execute a good product design critique is becoming a core competency for development teams.
Optimizing Your Product Development Process Through Team Collaboration: Strategies for Systems Engineers
For decades, systems engineers have participated in new product development processes on internal teams, driving complicated projects to market under old rules, methods, and technologies. But today’s highly-competitive markets offer new complexities that no longer work within the old rules of product development.
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.
Introducing the New and Improved Jama Connect Review Center
Jama Connect™ Review Center improves stakeholder alignment, reduces lengthy review cycles, and eases the path to compliance.
Legacy Sunset: Scalable Migration Solutions for Jama Connect
Customers leveraging our migration solutions will work with Jama Software consultants to adapt Jama Connect to fit their individual product delivery process, identify and migrate required data, and train teams to quickly achieve sustainable results.