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BioPharm & Medical Device Manufacturers Annual Checklist

Quality checklists are a great way to make sure you don’t forget the important things that keep your process and products in compliance. Here is a list of helpful items for Biopharm and Medical Device companies to consider annually. #QualityMatters

By |2020-01-24T21:21:11+00:00January 13th, 2020|Quality Checklist|0 Comments

FDA’s New Guidance for Medical Device Data System and Medical Image Storage

What's new for Medical Devices regulated by the U.S. FDA? Find out what you need to know regarding Medical Device Data Systems and Medical Image Storage.

By |2020-02-06T18:26:44+00:00October 8th, 2019|FDA Guidance|0 Comments

Getting Ready for a Quality Audit or FDA Inspection

What can I do to get ready for a quality audit or inspection by the U.S. FDA? Who do I need to prepare on my site? What do I do about known gaps in our systems? Read this article to learn more.

By |2020-02-06T18:44:38+00:00August 1st, 2017|Quality Checklist, Technical Article|0 Comments