Articles
Biological Evaluation
Blog
Case Studies
Engineering
FDA Compliance
Formwork eQMS Manual
Getting Started
IVDR Compliance
QMS Software
Quality Management
Regulatory News
Technical Documentation
Uncategorized
Clinical Evaluation
No image yet.

ISO 14971 Walkthrough
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps
Dr. Oliver Eidel
updated 9 months ago
No image yet.

DiGAs and the Telekom Cloud Run On Chinese Software From Huawei. Say What?
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Doing a Software Release in Compliance With IEC 62304
Dr. Oliver Eidel
•
1 comment
updated 9 months ago
No image yet.

Software System Testing Based on the IEC 62304
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Medical Device Software Architecture Documentation (IEC 62304)
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Software Verification For Medical Device Software (IEC 62304)
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Writing An Intended Use for Software as a Medical Device
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Choosing a Notified Body
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Setting Up a Quality Management System (QMS) in GitHub / GitLab
Dr. Oliver Eidel
updated 9 months ago
No image yet.

100.000€ Spent and Never Done (Fail)
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Getting The ISO 13485 And Other Standards For Less Than 30€
Dr. Oliver Eidel
•
2 comments
updated 9 months ago
No image yet.

Medical Device Classification
Dr. Oliver Eidel
updated 9 months ago
No image yet.

How to Classify Software as a Medical Device Under the MDR? (MDCG 2021-24)
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Writing Software Requirements Based on the IEC 62304
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Writing Technical Documentation
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance
Dr. Oliver Eidel
•
2 comments
updated 9 months ago
No image yet.

Four Problems For DiGA Companies In The Future
Dr. Oliver Eidel
updated 9 months ago
No image yet.

Don't Hire Senior Regulatory Affairs People
Dr. Oliver Eidel
updated 9 months ago
No image yet.

IEC 62304 Walkthrough
Dr. Oliver Eidel
updated 9 months ago