Author Bio
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.
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.
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.
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.
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.
Jama Connect™ Review Center improves stakeholder alignment, reduces lengthy review cycles, and eases the path to compliance.
Using Jama to manage requirements and Jira to monitor tasks separately is a totally viable solution for many product companies. Those forward-thinking businesses who take advantage of the powerful integration between the two see much stronger management of complexity, traceability, requirements and progress tracking.
See how medical device development company Össur uses Jama Connect to comply with with international medical device standards like ISO 13485 and ISO 14971.
Automakers continue to look toward the bright future of autonomous vehicles, but some are perhaps rightfully prioritizing safety over expediency.
Jama Software has partnered with Karl Wiegers to develop this 3 part blog series where he discusses techniques for defining project scope.