Medical Devices & Healthcare
ISO 13485 · MDA · DHF/DMR · CAPA · ISO 14971 Risk — MDA-licensed manufacturers
Medical Devices & Healthcare Portal
ISO 13485 · MDA · DHF/DMR · CAPA · ISO 14971 Risk — MDA-licensed manufacturers
ISO9001ISO27001ISO45001
Device Defect Rate
0.8%
-0.2%
Complaint Resolution Time
4.2 days
-0.8d
Audit Readiness Score
91%
+3%
Open CAPAs
7
-2
MDA Regulatory Alert
ISO 13485 surveillance audit due in 45 days. 2 DHF documents pending final approval. NPRA GMP inspection protocol updated May 2026.
Recommendation:
Prioritise DHF approval workflow. Ensure batch traceability evidence is packaged per updated NPRA protocol before audit.
ISO13485MDANPRADHFGMP
Regulatory Document Index
No documents found.
Approved: 0Under Review: 0Draft: 0