Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971
Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA, and 21 CFR Part 820.
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Frost & Sullivan: Jama Connect Improves Risk Management Amid Growing Product Complexity
Prominent research and consulting firm Frost & Sullivan recently observed the product development landscape and its relationship to risk. The output is a recently-released brief, “Safeguarding...
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Product Development Process: How Confident Are You That You Are Not at Risk?
In this post, Jama Software's CEO discusses how living requirements can help reduce the risk of negative outcomes in the product development process.
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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.
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Why You Need to Make More Time for FMEA
No one sets out to create a product that’s an abject failure, which is one of the reasons Failure Mode and Effects Analysis (FMEA) exists.
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How a Smarter Risk Management Process Improves Business
Improving your risk management process means safer products. In many cases, it can also give your overall business a boost that impacts efficiency, collaboration, and innovation.
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Avoid Product Recall and Failure with Better Requirements and Risk Management
Developing complex systems and products requires teams to have the ability to effectively define and track requirements, adhere to safety-critical regulations, collaborate and communicate...
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Gain Confidence in Your Risk Management Process with Jama Connect
Earlier this year, we introduced Jama Connect™ Risk Management Center for medical device developers, and now we’re excited to announce that we’re opening it up to all our customers working within...
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ISO 14971: Managing Risk for Medical Device Developers in Jama Connect™
Last week, Jama Software launched Jama Connect for Medical Device Development, which helps teams speed time-to-market without compromising quality or compliance. In our experience working with...
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Report: Preventing Medical Device Recalls More Critical Than Previously Thought
With more public attention than ever being paid to the fast-moving, competitive, lucrative and sometimes life-changing world of medical device development, it sounds obvious to say that no company...
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Why Risk Management, and Why Now?
After extensive industry research and interviews with customers in the medical device space, Jama saw an opportunity to provide a more straightforward, intuitive approach based on industry best...
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