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Tag: ISO 13485:2016

Sequana Medical announces 2023 Full Year Results and 2024 Outlook | BioSpace

PRESS RELEASEREGULATED INFORMATION – INSIDE INFORMATION28 March 2024, 08:00 a.m. CET alfapump® – PMA1 submitted to US FDA and accepted for substantive review, extensive feedback...

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Machine Learning, AI and Risk Management: TIR34971 Explained

TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. The technical report is a response to the AI...

Conducting Quality Investigations in Medical Device Manufacturing

When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and...

How do you demonstrate training competence?

Posted by Rob Packard on July 11, 2023 Anyone can sign and date training records, but how do you demonstrate the effectiveness...

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

As a medical device company, you are expected to deliver innovative, life-changing medical device(s) while ensuring compliance and achieving true quality. This task bears...

Clinical Investigation Plan (CIP): The Essential Guide

A clinical investigation plan (CIP) is an essential part of any medical device clinical trial. The CIP is a standalone document that includes...

15 Reasons Why Medical Device Companies Choose Greenlight Guru

MedTech companies are not just companies—they’re innovators building the medical devices that are saving and improving our quality of life.  But, bringing life-changing medical...

Hemant Surgical IPO GMP, Date, Price, Review, Allotment

Hemant Surgical Industries Limited is a leading Importer, Exporter, and manufacturer in Healthcare Sector. The company is based in Mumbai incorporated in 1989. The...

Ms. Reena Daga shares valuable Editorial Inputs in the MPO-MAG feature article “The New State of Outsourcing”! | Medical Device Contract Manufacturing – Johari...

Miss Reena Daga in conversation with Sean Fenske, Editor-in-Chief, MPO-MAG shared ground realities of the fast-evolving Medical Device Contract Manufacturing industry....

FDA US Agent – What do they do?

Posted by Rob Packard on May 9, 2023 Medical device companies exporting devices into the USA must have a US agent to...

FDA US Agent – What do they do?

Posted by Rob Packard on May 9, 2023 Medical device companies exporting devices into the USA must have a US agent to...

Nine easy ways to organize and improve quality system procedures

Posted by Rob Packard on March 28, 2023 Would you like to learn nine ways to improve your quality system procedures? One...

How to select and help validate the best sterilization method?

Posted by Rob Packard on February 7, 2023 The FDA eSTAR includes a list of eight different options for a sterilization method,...

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