QUALITY MANAGEMENT SYSTEM
SIC can provide practical and efficient SOPs for: ISO 13485:2016 MDSAP Thai GMP for Medical Devices, Good Distribution Practice for Medical Devices (GDPMD) Medical Device Directive (93/42/EEC) – CE Marking…
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PRE-MARKET SUBMISSION
Creation of US Pre-Market Notification (510k) Creation of Technical Documentation according to New EU Medical Device Regulation Consolidation and/or interpretation/translation of Common Submission Dossier Template (CSDT) according to ASEAN MDD…
OTHER SERVICES
Contact/Liaise with EU Authorized Representative on behalf of Product Owner/Manufacturer Import & Export Requirements Labeling & Advertising Review US Medical Device Reporting, EU Adverse Event Reporting Device classification according to…