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Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA, and 21 CFR Part 820.
Read this guide to learn the purpose of ISO 13485 and requirements for adherence, the difference between ISO 13485 and other medical device standards, and get key steps to adoption and certification.
Learn how using a single platform can help accelerate innovation, maintain consistency and high product quality, and manage ever-changing complex regulations in medical device development.
Learn what to look for in a medical device development platform to help accelerate the development of safe, high-quality devices while managing ever-shifting complexities and regulations.
For this information-packed eBook, Jama Software teamed up with Beanstock Ventures to weigh in on trends and predictions for medical device development in the new year and beyond.
Best practices for medical device design reviews, including the six necessary attributes when establishing a framework for planning and implementing a successful design review process.
40:11In this webinar, our experts outline how Jama Connect can help you reduce risk and accelerate innovation in medical device development.
Download this eBook to learn how medical device developers can prepare and implement the necessary changes to achieve compliance with the new EU MDR regulations.
In this infographic, you’ll learn how Jama Connect can help accelerate innovation, maintain product quality, and manage ever-changing complex regulations in medical device development.
59:20This webinar provides an overview of AAMI TIR45 guidelines for Agile — detailing how and why it should be used for safety-critical, regulated software development.
Learn more about how the Finnish Red Cross Blood Service leverages Jama Connect to modernize their processes, improve communication, and shorten review cycles.
Download this datasheet to learn how to analyze and mitigate potential failure modes or risks for medical device development to ensure quality and accelerate time to market.
Medical device companies must evaluate how their development process stands up to the challenge of increasingly connected technologies and strict regulation.
56:48This panel de-mystifies the beliefs that Agile development lacks the proper controls for producing safe and effective software and that the regulation is burdensome.
Global healthcare leader Grifols uses Jama Connect and Jama Professional Services to save time, reduce length of review cycles, and improve global communication.
Read this story to learn about the resulting dramatic improvements in efficiency and speed in Össur’s product development process, particularly around impact analysis, traceability, test management.
Read the story about how a leading dental company switched from a document-driven requirements management process to a more modern approach with Jama Connect.
Alight Solutions leveraged Jama Connect to help streamline requirements management processes, accelerate approvals, increase collaboration, and reduce rework.
Learn how Jama Connect, the leading solution for requirements, risk, and test management helps FDA-regulated companies comply with 21 CFR Part 11.