10-21
2024
FDA | Chemical Analysis for Biocompatibility Assessment of MD

08-26
2024
FDA | Electronic Submission Template for MD De Novo Requests

08-26
2024
EU | Laying Down Common Specifications for Certain Class D IVD

08-26
2024
FDA | Research of Pediatric and Perinatal Devices

08-26
2024
EU | Application of Hybrid Audits to QMS Assessments

08-12
2024
FDA | Discussion Paper: Health Equity For Medical Devices

08-12
2024
AE Reporting Guidelines for PCI Devices Manufacturer or AR

08-12
2024
AE Reporting Guidance for the MD Manufacturer or AR

08-12
2024
EU | On The Status of The EU Regulatory System

08-12
2024
FDA | Medical Device User Fee Rates for Fiscal Year 2025


