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Tag: Quality Management System

Overview of the New FDA Guidance on Cybersecurity

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides...

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NMPA Roundup March 2024

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2024. These updates are presented by...

789 Scaled Composites – Airplane Geeks Podcast

Podcast: Play in new window | Download (Duration: 1:20:04 — 36.7MB) We talk with both the President of Scaled Composites and the VP of Flight...

Similarities and Differences between Medical Device 510(k) and CE Marking

This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects...

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...

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...

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...

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...

What to Look for in an Aerospace Manufacturing Company | AMI

January 4, 2024 What to look for in an aerospace manufacturing company Aerospace fasteners are an integral component in the aerospace industry, providing security and support...

Cold chain: A cutting-edge supply chain management and logistics perspective – Schain24.Com

Spread the love Table of Contents Abstract Existing amenities are not enough to store, and deliver a large volume of vaccines within a short time, say experts...

SAHPRA Guidelines on Establishment Licensing: Introduction | RegDesk

The article highlights the key points related to the licensing regime for medical device establishments. Table of content The South African...

Three Imported Devices Found Defects in On-site Inspection

NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance,...

FDA eSTAR v5.0 – What’s new?

This blog provides a deep dive into the newest version of the FDA eSTAR, version 5.0, released on December 6, 2023. Why did the FDA...

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