White Paper
Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview
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About this Document
If you work in the medical device industry, you are aware of the importance of ISO 13485, also referred to as ISO 13485—Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes, and ISO 13485:2016. This white paper provides a brief, yet comprehensive, overview of the standard, as well as its newest version, and examines how obtaining ISO 13485 certification can open doors to untapped domestic and international business opportunities. It also explains how to avoid becoming a device company that fails to obtain recertification to the new revision due to inadequate manual processes.
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