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State of AI Regulatory Gap Analysis in 2025
How AI is transforming MDR, IVDR, and FDA submission readiness, and what teams should expect next.
FDA QMSR 2026 Readiness Checklist (ISO 13485 Alignment)
What QA/RA teams should do now for FDA’s Quality Management System Regulation (QMSR) transition targeting 2026.
Labeling and IFU Compliance Checklist (MDR + FDA)
A quick checklist to align labeling and IFU with MDR, FDA, and usability expectations.
Clinical Evaluation Report (CER) Outline for MDR
A concise CER structure covering CEP, data appraisal, equivalence, benefit-risk, and updates.
IVDR Performance Evaluation Checklist (PER)
Key elements for IVDR analytical performance, clinical performance, and scientific validity to strengthen your PER.
PMS and PMCF Plan Template for MDR Devices
A practical PMS/PMCF plan outline covering data sources, indicators, triggers, and reporting for MDR compliance.
EU MDR Technical Documentation Checklist (Annex II & III)
A concise MDR Annex II/III checklist for technical documentation, clinical evidence, and post-market plans.
ISO 14971 Risk Management File Template for MedTech Teams
Structure your ISO 14971 risk management file with practical sections, traces, and evidence expectations.
FDA 510(k) Submission Checklist for Software as a Medical Device
A practical 510(k) checklist for SaMD teams covering intended use, substantial equivalence, cybersecurity, usability, and documentation structure.
Supported Regulations - EU MDR, FDA 510(k), NDA, ANDA, and DSHEA
MedReg AI provides comprehensive gap analysis for medical devices, pharmaceuticals, and dietary supplements across major regulatory frameworks including EU MDR, FDA 510(k), NDA, ANDA, and DSHEA.
What is MedReg AI
MedReg AI is an AI-powered regulatory compliance platform that helps biotech and medtech companies automate FDA and EU MDR documentation gap analysis, saving time and reducing compliance costs.