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In this post, we’ll explore how Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training, and documentation aligned to industry regulations while applying a proven systems engineering approach to product development.
Medical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the impending EU MDR, it’s more important than ever to maximize every partnership.
Improve collaboration, quality, and delivery in medical device development by freeing your teams from document-based design control and risk management.
As medical device manufacturers develop complex products, they require a product development approach capable of managing that complexity. At the same time, manufacturers must continue to ensure compliance and alignment with regulations and standards. These define requirements that ensure safety and quality and reduce risk—but ultimately do not prescribe specific tools or techniques. This is especially apparent in design control activities. Regulatory requirements define the “what” for compliance but leave the “how” to the manufacturer, as long the procedures describing […]
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. […]
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 […]
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.
EU MDR which emphasizes patient safety, traceability, and transparency, will impact medical device developers, manufacturers, and suppliers across Europe.
3 improvement strategies to insert risk control as a crucial part of the medical device development framework to comply with ISO standards and EU MDR.
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.