ISO 13485

Five Reasons You Need the ISO 13485 Standard for Medical Devices

The increasing competition in the medical device production industry is threatening the existence and sustainability of small and medium-sized companies. Due to the ongoing pressure...

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Why is the ISO 13485 Standard for Medical Devices So Important for Companies?

The medical device manufacturing industry is a rapidly growing business sector around the world. With the combination of science and technology together they have revolutionized...

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What are the Key Medical Device Safety Requirements? Find Out

Quality management in the medical device industry is intrinsically linked to fulfilling certain safety requirements. The industry has been growing too fast with rapid innovation...

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Step-by-Step Internal Audit Checklist for Medical Device Companies

Hundreds of manufacturers and suppliers in the medical device industry are getting the international quality management standard ISO 13485. It is a specific standard that...

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What is the ISO Standard for Medical Devices: Here’s what you should know

Medical device manufacturers need to focus on the quality of their products in the first place to assure safety and effectiveness of the treatment services...

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Integration of ISO Standards Part 4

As part of an earlier blog on ISO Management System Standards integration, there were some items that needed expansion. In this blog, the following point...

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Quality Management System on an ISO 13485 : 2005

ISO 13485 focuses on defining a Quality Management System (QMS) for medical devices and services.  As one would expect devices and services used in the...

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