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Dr. Oliver Eidel

ISO 14971 Walkthrough

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

DiGAs and the Telekom Cloud Run On Chinese Software From Huawei. Say What?

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Doing a Software Release in Compliance With IEC 62304

Dr. Oliver Eidel 1 comment
updated 9 months ago
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Dr. Oliver Eidel

Software System Testing Based on the IEC 62304

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Medical Device Software Architecture Documentation (IEC 62304)

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Software Verification For Medical Device Software (IEC 62304)

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Writing An Intended Use for Software as a Medical Device

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Choosing a Notified Body

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Setting Up a Quality Management System (QMS) in GitHub / GitLab

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

100.000€ Spent and Never Done (Fail)

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Getting The ISO 13485 And Other Standards For Less Than 30€

Dr. Oliver Eidel 2 comments
updated 9 months ago
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Dr. Oliver Eidel

Medical Device Classification

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

How to Classify Software as a Medical Device Under the MDR? (MDCG 2021-24)

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Writing Software Requirements Based on the IEC 62304

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Writing Technical Documentation

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

Dr. Oliver Eidel 2 comments
updated 9 months ago
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Dr. Oliver Eidel

Four Problems For DiGA Companies In The Future

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

Don't Hire Senior Regulatory Affairs People

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

IEC 62304 Walkthrough

Dr. Oliver Eidel
updated 9 months ago