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SimplerQMS Pricing: Starts At $1,200
Dr. Oliver Eidel
updated 5 days ago
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eQMS Data Models: Hard-Coded Entities vs. Flexible Entities
Dr. Oliver Eidel
updated 6 days ago
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Is Your Medical Device Safe? Understanding Biological Evaluation
Sebastian Skorka
updated about 1 month ago
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Authorised Representative For Non-EU Manufacturers
Sebastian Skorka
updated about 1 month ago
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The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR
Sebastian Skorka
updated about 1 month ago
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Medical Device Codes: EMDN, UMDNS, GMDN and MDR
Sven Piechottka
updated 2 months ago
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OpenRegulatory Sustainability & Governance: Will We Be Around 5 Years From Now?
Dr. Oliver Eidel
updated 4 months ago
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FormlyAI Pricing: Not Good For Startups
Dr. Oliver Eidel
updated 4 months ago
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How to Document Separate Medical Device Software Components
Sven Piechottka
updated 6 months ago
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QT9 Pricing: Costs, Contracts, and Uncertainties
Dr. Oliver Eidel
updated 6 months ago
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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 6 months ago
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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
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1 comment
updated 7 months ago


EUDAMED: Duplicate And Missing Certificates (BEUDAMED November 2024 Update)
Dr. Oliver Eidel
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4 comments
updated 8 months ago
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Support Us: Link To OpenRegulatory
Dr. Oliver Eidel
updated 8 months ago
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How To Purchase Formwork With The Startup Discount
Dr. Oliver Eidel
updated 4 months ago
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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
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Medical Device Accessories
Sven Piechottka
updated 9 months ago