Medical Device Regulatory Resources
Expert guides, templates, and insights to help you navigate ISO 13485, FDA compliance, and the global regulatory landscape.
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ISO 13485 Implementation Roadmap
A step-by-step guide to building a compliant Quality Management System from scratch.
2026 QMSR Transition Update
Critical analysis of the FDA’s alignment with ISO 13485 and what it means for your QMS.
Cost of Inaction Calculator
Quantify the daily financial impact of regulatory delays on your Class III device launch.
ISO 13485 Implementation Roadmap
A step-by-step guide to building a compliant Quality Management System from scratch.
2026 QMSR Transition Update
Critical analysis of the FDA’s alignment with ISO 13485 and what it means for your QMS.
Cost of Inaction Calculator
Quantify the daily financial impact of regulatory delays on your Class III device launch.
FDA 21 CFR Part 820 Checklist
Self-assessment tool to verify your current compliance status against FDA requirements.
Gap Analysis Template
Standardized matrix for identifying discrepancies between your QMS and MDSAP requirements.
MDSAP Audit Strategy Guide
How to prepare your team for the specific rigors of the Medical Device Single Audit Program.
EU MDR Clinical Evaluation Report
Key changes in clinical data requirements for legacy devices under the new MDR.
CAPA Process Flowchart
Visual aid for distinguishing between corrections, corrective actions, and preventive actions.