Design Control: From Evolution to Commercialization

Are you in the early stages of design development of a product? Or do you need help remediating your Design History File? This White Paper will provide guidance on the global requirements of design control and the documented evidence needed to meet global regulatory...

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 flexibility!...

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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