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510(k) Services

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Electrical Safety

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510(k) Resources

510(k) Demo Project FDA Database for Research Regulatory Analytics eSTAR Guide FDA eSTAR Templates Predicate Analysis Substantial Equivalence Cybersecurity (SAMD) Risk Analysis (ISO 14971) Fees & Timeline Labeling & IFU FDA 510k Consultant vs AI Checklist Guide

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EU/UK Representatives

Browse Directories

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EU Cosmetics

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EU/UK Medical Representatives

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Medical Device Support

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Non-EU Regulatory Reps

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Testing & Enforcement

Testing Services

Electrical Safety + EMC Testing (IEC 60601) Wireless / RF Testing (FCC / RED / ISED) Biocompatibility Testing (ISO 10993 Program) Sterilization + Microbiology Validation Packaging + Shelf-life + Distribution Testing Usability / Human Factors Testing

FDA Enforcement & Recall

FDA Import Alert & Detention Assistance Form 483 Response Team Form FDA 483 Response Provider Directory Form FDA 483 Readiness Calculator Form FDA 483 CAPA Timeline Calculator Form FDA 483 Remediation Cost Calculator Recall & 21 CFR 806 Support Recall & 21 CFR 806 Provider Directory 21 CFR 806 Reportability Decision Calculator Recall Action Timeline Calculator Recall & 806 Remediation Cost Calculator

FDA U.S. Agent Information

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Cost Calculators

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General Resources

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Cruxi research & evidence

Medical Device Cybersecurity evidence guides — page 3

Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.

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