Part I: [Answered] How to Accelerate Your Automotive SPICE (ASPICE) Capability
In Part I of our six-part automotive series, our experts discuss how to accelerate automotive SPICE (ASPICE) capability with Jama Connect for Automotive.
Archive for category: Compliance & Regulation Page 9
Navigating Medical Device Compliance: 6 Key Tips
August 25, 2020 in Compliance & Regulation Medical Device & Life Sciences /by Jama SoftwareBased on our work with hundreds of medical device developers, we’ve compiled this guide to navigating the complexity of medical device compliance.
Getting the Most Out of Your Lab Partnership Ahead of the EU’s MDR
July 30, 2020 in Compliance & Regulation Medical Device & Life Sciences /by Jama SoftwareMedical 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.
How to Choose the Right Tool for ASIL D Requirement Management ISO 26262 / IEC 61508
June 9, 2020 in Compliance & Regulation Automotive /by Jama SoftwareHow to Choose the Right Tool for ASIL D Requirement Management ISO 26262 / IEC 61508 Editor’s Note: This posts on tool selection around ASIL D requirement management for ISO 26262 / IEC 61508 was originally published here by LHP Engineering Solutions and written by Steve Neemeh. When the options for choosing a requirements management […]
An Interview with Velentium: How Medical Device Developers Can Prepare for EU MDR
February 11, 2020 in Compliance & Regulation Medical Device & Life Sciences /by Satyajit KetkarEU MDR which emphasizes patient safety, traceability, and transparency, will impact medical device developers, manufacturers, and suppliers across Europe.
Increasing Efficiency in Testing and Confidence in Safety Standard Compliance
February 6, 2020 in Compliance & Regulation Aerospace & Defense, Automotive /by Jama SoftwareTesting manually can lead to the introduction of errors, inconsistencies in code analysis, delays in project timelines, and recalls or safety standard compliance failure
2020s Predictions: Get Ready for More Regulations
December 12, 2019 in Compliance & Regulation /by Jama SoftwareThoughts on the decade ahead from Josh Turpen, Chief Product Officer at Jama Software, who oversees the ongoing innovation and refinement of our core product offerings.
The Importance of ISO 26262 in Automotive Development
December 3, 2019 in Compliance & Regulation Automotive /by Jama SoftwareWhen teams aren’t set up with the right tools, implementation strategies, and best practices, compliance with ISO 26262 becomes an afterthought — and an auditing nightmare.
How the FDA’s New Safety and Performance Based Pathway Could Affect Medical Device Development
November 21, 2019 in Compliance & Regulation Medical Device & Life Sciences /by Jama SoftwareThe 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.
5 Updates Pending to the FDA’s Cybersecurity for Premarket Submissions
October 31, 2019 in Compliance & Regulation Medical Device & Life Sciences /by VelentiumIn this post, we offer insight into anticipated changes coming in the official update.