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Tag: quality system

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...

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Navigating the Future: Insights from the 13th China International Medical Device Regulatory Forum (CIMDR) and Anticipating the 14th CIMDR in 2024

As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...

FDA Guidance on CFG Requests: Introduction | RegDesk

The new article provides an overview of the new guidance document dedicated to the processes and procedures associated with the review of certain regulatory...

FDA Guidance on Fostering Medical Device Improvement: Submission Formats – RegDesk

The article highlights the aspects related to existing submission formats and key considerations associated thereto in the context...

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...

Hiring an Auditor

In this article, you will learn how to hire an auditor to conduct medical device internal audits and supplier audits. Hiring an auditor, whether...

Predicate selection guidance proposes controversial additions

The FDA released a new draft 510k predicate selection guidance on September 7, but the draft guidance proposes controversial additions. On September 7, 2023, a...

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...

Design Controls Implementation

Posted by Rob Packard on August 30, 2023 Design controls can be overwhelming, but you can learn the process using this step-by-step...

Omnibus Act Impact on Medical Device Cybersecurity

The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022....

7 Supply Chain Strategies Pharma Brands Can Use Against Generic Drugs

This post has already been read 199 times! How pharmaceutical brands can use a multi-party, multi-tier network to achieve operational excellence and combat the competition In...

Test Flying The F-35: Interview With Monessa ‘Siren’ Balzhiser

We talked about the F-35’s current and future capabilities; differences with the F-16 in the SEAD and CAS missions; and much more, with Lockheed...

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