Useful Information

2026.01.13

FDA Draft Guidance on Cybersecurity in Medical Devices

2026.01.13

Evaluation Standards for Medical Device Programs with Behavioral Intervention Components

2026.01.13

Strengthening Cybersecurity Measures for Medical Institutions and Medical Devices (Request)

2026.01.13

FDA Proposes Amendment to QSR to Harmonize with ISO 13485

2026.01.13

CAPA Initiation Criteria: When to Raise Corrective and Preventive Actions

2026.01.13

FDA QSR Harmonization with ISO 13485

2026.01.13

When Must a Marketing Authorization Holder License Be Obtained?

2026.01.13

Is Verification Unnecessary if Validation is Performed?

2026.01.13

Is ISO 13485 Certification Mandatory?

2026.01.13

The 4M Change Management Framework in Medical Device Regulation