FDA QMSR Eight Months In: Why an ISO 13485 Certificate Is Not Enough
The QMSR builds on ISO 13485, but FDA-specific requirements still apply — plus an MDSAP roadmap and a self-check list.
Indonesia’s KMK 951/2026 Takes Effect: Imported AI Software Needs Local Clinical Validation
Indonesia’s new software and AI medical device guidelines apply immediately, with local clinical validation for imported AI.
UK Confirms Indefinite Recognition of CE-Marked Medical Devices: Good News, but 5 UK Obligations Remain
The UK will indefinitely recognise EU MDR / IVDR CE-marked devices — but UK local obligations remain.