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Tag: Quality Management

Medical Device Companies Annual Self-Inspection Report Due March 31

All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 719 “Medical...

What Is Procurement? Process, Strategies, and Automation

Procurement is a pivotal function for any business upon which the pillars of strategic sourcing and cost management rest. This is more than just...

Outlook 2024 with Dr. Laura Matz Chief Science and Technology Officer for Merck KGaA – Semiwiki

Prior to becoming the CTO, she was a senior vice president within EMD Electronics (previously Versum Materials and Air Products Electronics division). She has...

Test Plan Webinar

In this webinar, you will learn how to prepare a verification and validation test plan for your 510(k) or De Novo submission. Your cart is...

NMPA Roundup February 2024

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device,...

Patent Office Issued 230 Patents to Indiana Entities in December 2023

The U.S. Patent Office issued the following 230 patents to persons and businesses in Indiana in December 2023: PATENT NUMBER                                    PATENT TITLE US 11851685 B2 Zwitterion buffer containing...

Medical Device GSP Announced

NMPA released “Quality Management Measures for Medical Device Operations”, on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was...

Understanding the Impact of Bad Data – DATAVERSITY

Do you know the costs of poor data quality? Below, I explore the significance of data observability, how it can mitigate the risks of bad...

Urban mobility transformation enhances the “Fast” but remove

Commissioned After two years of collective confinement, the world's population rushed outdoors with a passion. People want to go further, faster, to more places:...

Nanoflex Robotics Receives ISO 13485 CertificationThe innovative medical robotic startup achieved the globally recognized ISO 13485 certification in December 2023 | BioSpace

ZURICH, Switzerland, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Nanoflex Robotics AG, a remote robotic surgical company based in Switzerland, has received the internationally recognized...

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