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Tag: QMS

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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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...

Inspiring Inclusion – Women in STEM

This year’s International Women’s day theme is ‘Inspire Inclusion’. In this blog I’ll share statistics around women in Science, Technology, Engineering and Mathematics (STEM)...

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...

News From Infleqtion: Inertial Sensors, Atomic Clocks, RF Receivers… oh, and 1,600 Qubits: by Brian Siegelwax – Inside Quantum Technology

By Kenna Hughes-Castleberry posted 09 Feb 2024 On February 8, 2024, Infleqtion held its inaugural webinar titled “Infleqtion’s...

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,...

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,...

Global Digital PR and Communications Service Provider ‘MediaValueWorks’ receives ISO 9000-2015 Certification for Quality Management

MUMBAI, INDIA, Dec 15, 2023 - (ACN Newswire) - MVW Network International Pvt Ltd, a pioneering leader in 'Marketing Communication Services' proudly announces its successful...

AliveDx secures IVDR certification for sites in UK and Switzerland

Switzerland-based vitro diagnostic company AliveDx has announced it received an In Vitro Diagnostic Regulation...

NMPA Roundup October 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by...

Navigating the Regulatory Maze: How PSC Biotech Lights the Way

Regulatory affairs (RA) is a profession in the life science industry that involves checking whether a...

How pharmaceutical manufacturers can guarantee a seamless eIFU implementation

<!----> Implementing an eIFU-platform is a significant undertaking. But the potential benefits more than making up for this;...

MDR Extension Timeline for Implementation

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

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