eu-mdr-gspr-mapper

EU MDR General Safety and Performance Requirements (GSPR) mapping and compliance documentation skill

a5c-ai

244

fda-510k-submission-generator

Automated 510(k) premarket notification preparation for generating submission packages, predicate device comparisons, and substantial equivalence arguments

a5c-ai

244

iso-standards-compliance-checker

Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards

a5c-ai

244

udi-labeling-generator

Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers

a5c-ai

244