Medical Device & Life Sciences

Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device development.

Download this datasheet to learn how Jama Connect for Medical Device & Life Sciences Development accelerates innovation in medical device development while adhering to industry regulations.

The new Medical Device Regulation (EU MDR) addresses software as a medical device (SaMD), as well as other products. Here, we cover the new regulations and highlight the most important changes.

Read this customer story to learn more about the value of a requirements-driven product development process and the limitations of the typical Quality Management System (QMS)

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.

Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA, and 21 CFR Part 820.

In this customer story, we cover how Microsure leverages Jama Connect® to involve all team members in development, efficiently manage change, and quickly provide necessary regulatory documentation.

See how Jama Connect® for Digital Health helps medical device development teams accelerate innovation in digital health solutions while adhering to industry regulations.

Jama Connect® Medical Device Risk Management Package helps customers manage advanced risk activities to support their desired risk management strategy.

Why choose Jama Connect® over Polarion for requirements managementt? Jama Connect is the ONLY solution that enables Live Traceability™ across best-of-breed tools for ocmplete end-to-end traceability.

In this customer story, we discuss why Monogram Orthopedics switched from Polarion® ALM to Jama Connect for faster time-to-market and an overall streamlined product development process.