Medical device manufacturing and marketing in the U.S.A. is regulated by the FDA. Medical device manufacturers must register with the FDA and produce their products with a Quality System that meets the FDA Quality System Regulation and more precisely with the 21 CFR 820. Compliance with regulations is crucial and requires an investment of both […]
Developing products with highest quality standards is essential for medical device manufacturers. Having been certified to both ISO 9001 and ISO 13485 for the past decade, Valtronic and quality manufacturing are long time companions. However, is […]
One would quickly describe the position of Document Control as the “police” of an organization that maintains tight jurisdiction and follows strict guidelines to controlling all aspects of internal documentation.
As I am working on entering first pass yield data into a system I have created for Valtronic, I am reminded of past businesses that I have worked for. In those positions, the Quality system (or Quality Management System – QMS) was a key identification tool to help businesses and their customers thrive. The QMS systems […]
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