[Webinar Recap] My Software Is a Medical Device (SaMD) – Now What?
In this webinar recap, we discuss the general medical device safety and performance principles of Software as a Medical Device (SaMD) development.
New Search
Can't find what you're looking for? Try another search!
29 search results for:
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 more than 200 medical device developers, we’ve realized how important it is to create best practices for risk management under ISO 14971, the FDA’s mandatory standard for risk assessment throughout the product development lifecycle. […]
What is Medical Device Risk Management?
Building and then bringing a medical device to market as quickly as possible—all while preserving acceptable levels of quality and regulatory compliance—requires adept medical device risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks […]
An Interview with Award-Winning Medical Device Risk Management Educator and Author Bijan Elahi
We sat down with award-winning medical device risk management educator, author, and consultant Bijan Elahi to hear his thoughts on risk management in medical device development.
A Developing Story: Grifols Reduces Medical Device Development by 80 Hours Using Jama Connect
Grifols increases efficiency and cuts costs by optimizing their requirements and risk management process with Jama Connect.
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.
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 effectively across teams and functions, and evaluate and mitigate potential risks.
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 regulated industries with the introduction of FMEA templates.
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 Regulated Products Amidst Growing Complexity,” that spotlights Jama Connect™ as a remedy for ineffective risk analysis in product development.