White Paper

The Evolution of a QMS

The Evolution of a QMS

It is so important to develop your Quality Management System (QMS) around: your medical products, your organizational structure, your company’s maturity, and your global strategy. Both FDA’s Quality System regulation and ISO 13485:2016 give you this...

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Right Sizing Your Quality Management System

Right Sizing Your Quality Management System

Determining the right size of a Quality Management System (QMS) can make some feel like they are on a roller coaster ride and not know how to navigate the numerous drops and turns. Although developing a QMS is a requirement, it does not need to be overwhelming....

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White Paper – Transition Plan for COVID19 EUAs

White Paper – Transition Plan for COVID19 EUAs

White Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency. The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the...

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