Tag: quality system

Create powerful self-service experiences with Amazon Lex on Talkdesk CX Cloud contact center

AIFebruary 6, 2023

This blog post is co-written with Bruno Mateus, Jonathan Diedrich and Crispim Tribuna at Talkdesk. Contact centers are using artificial intelligence (AI) and natural...

FDA Draft Guidance on the Content of Human Factors Information: Recommendations

Medical DevicesFebruary 3, 2023

The new article describes the recommended content and highlights the key points to be considered in this respect....

ISO 19011 – Do you need this quality system auditing standard?

Medical DevicesJanuary 31, 2023

Posted by Rob Packard on January 31, 2023 Read this article to learn why ISO 19011 standard is a vital guidance for...

New Cybersecurity Requirements in the US

Medical DevicesJanuary 30, 2023

Cybersecurity is a key consideration in today’s market for medical device manufacturers and other industries. I have previously written about the FDA’s expectations for...

Software security, what is the best time to test cybersecurity?

Medical DevicesJanuary 24, 2023

The new US FDA draft cybersecurity guidance requires you to test cybersecurity, but when should you conduct software security testing? The 2022 draft cybersecurity guidance...

Why modernize 21 CFR 820 to ISO 13485?

Medical DevicesJanuary 9, 2023

Posted by Rob Packard on January 10, 2023 The FDA patches the regulations with guidance documents, but there is a desperate need...

Lexus Bringing Nanoe X Air Quality System To More Models In Europe

AutomotiveDecember 13, 2022

Listen to this article Lexus is eventually rolling out Panasonic's Nanoe X air quality system to all of its models...

Lifecycle Checkpoints of Cosmetic Devices Released

Medical DevicesNovember 30, 2022

NMPA issued the “Checkpoints of Common Violations of Regulations in the Production, Supply and Usage of Medical Cosmetic Devices” on November 25, 2022. It...

Software validation documentation for a medical device

Medical DevicesNovember 29, 2022

Learn why you need to start with software validation documentation before you jump into software development.At least once a week, I speak with the...

Medeologix Acquires Three Silicon Valley Medical Device CDMO Companies and Establishes One-Stop Shop Mass Production Facilities in Taiwan

Medical DevicesNovember 27, 2022

NEW TAIPEI CITY, Taiwan, Nov. 28, 2022 /PRNewswire/ -- Medeologix, a Taiwan MedTech CDMO company announces its successful acquisition of three premier...