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Institute for Medical Device Compliance & Regulations

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From paper-based to eQMS – Problem naming files

July 4, 2019June 17, 2020

Versions and revisions! Document control in eQMS software

June 27, 2019June 27, 2019

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Explained: Planning of product realization in ISO 13485:2016 (part 1)
Explained: Contamination Control by ISO 13485
Infrastructure requirements in ISO 13485
Work Environment as per ISO 13485
Human resources in ISO 13485

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