MDSAP: Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) provides medical device manufacturers an option...
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21 CFR Part 820 Quality System Regulation [Role of an eQMS]
Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed...
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CE Marking for Medical Devices [Step-by-Step Guide]
To sell your medical device across the European Union, you must have a CE marking of conformity....
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Vendor Management Process in Clinical Research [How-To Guide]
Imagine yourself in the shoes of a lead clinical investigator or a seasoned product manager...
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EU MDR Quality Management System [Role of an eQMS]
The tough part for the medical device industry is that this landscape of regulations is constantly...
Laboratory Document Control: A Simple (But Complete) Guide
An efficient laboratory document control system is essential for the lab manager to keep records...
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ISO 13485 Quality Management System [Role of an eQMS]
ISO 13485 is an internationally recognized Quality Management System (QMS) standard for the...
5 Steps for Pharmaceutical Vendor Management Success
When you are a pharmaceutical company that is conscious of quality and your primary focus is to...
Medical Device Supplier Management Process (8 Steps)
In the international arena that is filled with medical device companies that assert that their...
Electronic Batch Records: What They Are & How to Get Started
Batch Records are testimony to the fact that your life sciences company is recording all crucial...