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Navigate Global Regulation with Confidence
Audit-ready documentation, expert consulting, self-audit tools and
online training for medical device companies — ISO 13485, EU MDR, FDA QMSR,
MDSAP and beyond.
✓ Online Training Courses
✓ ISO 13485 · EU MDR · FDA QMSR
✓ 10+ Markets Covered
MD Regulatory Academy
Online training, one subject at a time
The fastest way to start. Each course takes a single area of the regulation and works through it completely — the requirements, the evidence, and the documents that result.
Medical Device Software Verification and Validation
What the lifecycle standards require of the documentation, and how the parts have to trace to each other.
Post-Market Surveillance Requirements
The surveillance loop end to end, from the plan that starts it to the file that records what it changed.
Clinical Evaluation according to EU MDR 2017/745
From the plan that decides what has to be demonstrated to the report somebody else assesses.
Artificial Intelligence in Medical Devices — Regulatory Requirements
Qualification and classification of AI-driven devices, the evidence expected of a learning system, and how the AI Act sits alongside the MDR.
EN 18286 in Practice: The Quality Management System Required by the EU AI Act
The quality management system Article 17 requires of a provider of a high-risk AI system, clause by clause, and what it adds to an ISO 13485 system already in place.
More subjects in preparation: biological evaluation, materials of animal origin and UDI management.