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Global Harmonization Task Force. A New Way to Grade Findings. On March 24, 2013. Last November a new GHTF. Document was released on the topic of grading non-conformities: GHTF/SG3/N19:2012. This document is available on the new IMDRF website. In the documents section. The 16-page document presents a new method for Certification Bodies to grade non-conformities and to communicate these findings to regulators such as the US FDA and Health Canada (e.g. GD211 voluntary reports). The new grading process defin...
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QMS 13485 Certification Requirements | Information about QMS 13485 certification requirements and procedures for medical devices
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ISO 13485 Medikal Cihazlar Belgelendirme
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Welcome to the ISO 13485 Standard - Quality management medical devices knowledge center
Quality Management System requirements. Production and Service Provision. Measurement Analysis and Improvement. Welcome to the ISO 13485 Standard - Quality management medical devices knowledge center. Welcome to the ISO 13485 Standard - Quality management medical devices knowledge center. ISO 13485 Standard - 4.2.3 Control of Documents. ISO 13485 Standard - 8.2.1 Feedback. The organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life ...
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