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Quality Management System
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ISO 13485 Software – What do I need to know?
October 23, 2022,
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Practical FAQ about ISO 13485
September 26, 2022,
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FDA QSR 21CFR 820 Transition to ISO 13485:2016 – FAQ
September 20, 2019,
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Software Validation ISO 13485 – Validation of Software applications
June 11, 2018,
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Product Realization
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7.3.7 Design and development validation – Objectives
September 15, 2018,
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Challenges manufacturers of medical devices are facing when implementing labels under the ISO 13485
August 12, 2018,
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The challenges of Computer Systems Validation (CSV)
July 31, 2018,
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ISO 13485:2016 Standard – 7.5.8 Identification
June 12, 2018,
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Resource Management
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ISO 13485:2016 Standard – Maintaining documented procedure for Human resources
September 15, 2018,
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ISO 13485:2016 Standard – 6.4.2 Contamination control
June 12, 2018,
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ISO 13485:2016 Standard – 6.3 Infrastructure
June 11, 2018,
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Measurement, analysis and improvement
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ISO 13485 Standard:2016 – 8.3.4 Rework
September 15, 2018,
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ISO 13485 Standard:2016 – 8.5.2 Corrective Action
June 12, 2018,
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ISO 13485:2016 Standard – 8.2.1 Feedback
June 12, 2018,
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ISO 13485:2016 Standard Section 7 – Product realization
ISO 13485:2016 Standard Section 8 – Measurement, analysis and improvement
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