[GUIDE] ISO 13485 for Medical Device Development
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
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A Guide to Understanding ISO Standards
If you’ve worked in product development for any time at all, you’ve probably heard the term “ISO” used in conjunction with the terms “standards” and “compliance” (along with a variety of four- and five-digit numbers). But what does that all mean, and how does it affect you? In this article, we will provide you with […]
How Jama Software’s TÜV SÜD Certification Helps Customers Build Safer Products
In this post, we discuss our partnership with internationally-recognized testing body TÜV SÜD, and how it helps our customers bring safer products to market.
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. […]
Close the Gaps in Your Product Development Cycle with Jama Connect™ and LDRA
Close gaps in product development with Jama Connect™ and LDRA Interested in closing gaps in your product development lifecycle? It’s no secret that developers of mission-critical software are facing increasingly complex system requirements and stringent standards for safety and efficacy. That’s why Jama Software has partnered with LDRA to deliver a test validation and verification […]