An Interview with Velentium: How Medical Device Developers Can Prepare for EU MDR
EU MDR which emphasizes patient safety, traceability, and transparency, will impact medical device developers, manufacturers, and suppliers across Europe.
Archive for category: Compliance & Regulation Page 12
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.
Why You Need to Make More Time for FMEA
July 2, 2019 in Compliance & Regulation /by Jama SoftwareNo one sets out to create a product that’s an abject failure, which is one of the reasons Failure Mode and Effects Analysis (FMEA) exists.
Report: Preventing Medical Device Recalls More Critical Than Previously Thought
March 5, 2019 in Compliance & Regulation Medical Device & Life Sciences /by Kevin SmithWith more public attention than ever being paid to the fast-moving, competitive, lucrative and sometimes life-changing world of medical device development, it sounds obvious to say that no company wants to experience a product recall.
Avoid the Most Common Challenges of the Design History File
October 3, 2018 in Compliance & Regulation Medical Device & Life Sciences /by Jama SoftwareIn a recent webinar about the common pitfalls of the Design History File (DHF), experts discussed what medical device manufacturers need to know about design compliance.
Seizure-Detecting Smart Watch Receives FDA Approval
March 6, 2018 in Compliance & Regulation /by Courtney KruegerEarly detection and warning systems for epilepsy sufferers can save lives or prevent serious injury brought on by a severe convulsive seizure, and Empatica has positioned itself to be one of the leaders on developing that critical technology.