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This guidance document is intended for medical device manufacturers and regulatory authorities. It is intended for educational purposes and is not intended to be used to assess or audit compliance with regulatory requirements. It is expected that the reader is familiar with regulatory Quality Management System (QMS) requirements within the medical devices sector.
For the purposes of this document, it is assumed that the medical device manufacturer has a QMS which requires the manufacturer to have documented processes to ensure that medical devices placed on the market are safe and effective. For example ISO13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes, Japanese Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and in vitro Diagnostics (MHLW1 Ministerial Ordinance No. 169), the FDA2 Quality System Regulation 21 CFR Part 820 or the respective quality system requirements of the European Medical Device Directives.

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