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July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
Dr. Oliver Eidel
updated 9 months ago
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Open Source QMS Software Overview: GitLab As QMS?
Dr. Oliver Eidel
updated 9 months ago
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Supplier Management Under ISO 13485:2016
Sören Hornof
updated 9 months ago
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Maybe Harmonized Standards Are Becoming Freely Available Soon
Dr. Oliver Eidel
updated 9 months ago
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How To Do a Summative Usability Testing For IEC 62366 Compliance
Dr. Oliver Eidel
updated 9 months ago
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The IEC 62366 (Usability) Summary: All You Need To Know (It's Not Much)
Dr. Oliver Eidel
updated 9 months ago
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People You Need: Person Responsible for Regulatory Compliance and Medical Device Consultants
Dr. Oliver Eidel
updated 9 months ago
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MDD Class I: Here's What You Have to Do Before May 2021
Dr. Oliver Eidel
updated 9 months ago
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Do We Need a Call?
Dr. Oliver Eidel
updated 9 months ago
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Before Our Call: Frequently Asked Questions
Dr. Oliver Eidel
updated 9 months ago
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How We Keep Your Formwork Data Safe
Dr. Oliver Eidel
updated 9 months ago
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Is Formwork an Enterprise Software? Does It Have [Enterprise Feature X]?
Dr. Oliver Eidel
updated 9 months ago
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Setting Up a Quality Management System (QMS) in Google Drive
Dr. Oliver Eidel
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updated 9 months ago
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GitHub QMS: We No Longer Recommend It
Dr. Oliver Eidel
updated 9 months ago
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Clinical Evaluation: How to Write a Regulatory Compliant Literature Review
Dr. Oliver Eidel
updated 9 months ago
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Enterprise QMS Software: Don't Waste Your Money
Dr. Oliver Eidel
updated 9 months ago
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Medical Device Translation: 3 Steps For Medical Device Software
Sven Piechottka
updated 9 months ago
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What Is QMS Software, and Do You Need It?
Dr. Oliver Eidel
updated 9 months ago
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How to Get a UDI (Unique Device Identifier) For MDR Compliance
Dr. Oliver Eidel
updated 9 months ago
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FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)
Dr. Oliver Eidel
updated 9 months ago