Articles By: Jama Software
Resolving the Challenges of Connectivity, Competition & Compliance for Modern Medical Device Makers
For medical device manufacturers, new realities present favorable circumstances and worrisome challenges. For example, medical devices are now more integrated into inpatient, outpatient and home care. And technological advances continue to evolve medical device design and manufacturing. But as modern health reform increases patient connectivity, it also increases media scrutiny, leaving manufacturers with precious little margin for error.
Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971
Medical technology companies especially those developing medical devices are faced with a wide range of techniques for managing risk. The hardest part is often deciding which specific techniques and data points need to be captured to demonstrate that all angles of risk analysis for the product have been accounted for.
Testing the Requirements
It’s hard to visualize how a system will function just by reading the requirements specification. Designing tests based on requirements will help make the expected system behaviors more tangible to all the project participants. And the simple act of designing tests often reveals many problems with the requirements long before you execute the tests on an operational system.
Requirements Management 101 for Semiconductor Suppliers
Semiconductor engineers in the automotive industry understand the fundamental importance of requirements management (RM), but many critical stakeholders don’t. The challenge with this disparity comes when implementing RM in a modern development environment. From technical specs hundreds of pages long to coordinating cross-functional deliverables, the complications are abundant.
Project Management Best Practices
Managing software projects is difficult under the best circumstances. The project manager must balance competing stakeholder interests against the constraints of limited resources and time, changing technologies and high-pressure demands. Anyone can learn to draw a Gantt chart, but effective project managers rely on the savvy that comes from experience.
Top Five Frustrations of Requirements & Tips to Avoid Them
Every year, the complexity of projects increases. The average requirements document is over 100 pages long and changes 20 times during the development process.
Systems Complexity Trends in Aerospace & Defense
Executing a successful development program on time and on budget has always been a challenge for government agencies and partners in the aerospace and defense (A&D) industry. With today’s relatively flat economy, globalization, product sophistication and the continuing emergence of new technologies, the level of complexity in A&D product development is now staggering.
Top 15 ISO 26262 Snafus
What do golf and automotive software have in common? To the novice, seemingly nothing. However, the commonalities are more profound than expected.
