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.
SimplerQMS Pricing: Starts At $1,200
Dr. Oliver Eidel
updated 9 days ago
No image yet.
eQMS Data Models: Hard-Coded Entities vs. Flexible Entities
Dr. Oliver Eidel
updated 9 days ago
No image yet.
S
Is Your Medical Device Safe? Understanding Biological Evaluation
Sebastian Skorka
updated about 1 month ago
No image yet.
S
Authorised Representative For Non-EU Manufacturers
Sebastian Skorka
updated about 1 month ago
No image yet.
S
The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR
Sebastian Skorka
updated about 2 months ago
No image yet.
Medical Device Codes: EMDN, UMDNS, GMDN and MDR
Sven Piechottka
updated 2 months ago
No image yet.
OpenRegulatory Sustainability & Governance: Will We Be Around 5 Years From Now?
Dr. Oliver Eidel
updated 4 months ago
No image yet.
FormlyAI Pricing: Not Good For Startups
Dr. Oliver Eidel
updated 4 months ago
No image yet.
How to Document Separate Medical Device Software Components
Sven Piechottka
updated 6 months ago
No image yet.
QT9 Pricing: Costs, Contracts, and Uncertainties
Dr. Oliver Eidel
updated 7 months ago
No image yet.
QMS Quality Manual: Quality Policy and Quality Objectives
Sven Piechottka
updated 7 months ago
Matrix Requirements Got Sold: Here's What You Need To Know
Dr. Oliver Eidel
updated 7 months ago
No image yet.
Matrix Requirements Pricing: Huge Price Increase In 2024
Dr. Oliver Eidel
updated 7 months ago
The EUDAMED Files: €9M/Year Budget and a €317K Hosting Mystery
Dr. Oliver Eidel
•
1 comment
updated 7 months ago
EUDAMED: Duplicate And Missing Certificates (BEUDAMED November 2024 Update)
Dr. Oliver Eidel
•
4 comments
updated 8 months ago
No image yet.
Support Us: Link To OpenRegulatory
Dr. Oliver Eidel
updated 8 months ago
No image yet.
How To Purchase Formwork With The Startup Discount
Dr. Oliver Eidel
updated 4 months ago
No image yet.
Greenlight Guru vs. Qualio: QMS Software Comparison
Dr. Oliver Eidel
updated 9 months ago
EUDAMED: How To Use It, And Why It Sucks
Dr. Oliver Eidel
updated 9 months ago
No image yet.
Medical Device Accessories
Sven Piechottka
updated 9 months ago