COURSE OUTLINE Due to the complexity of today’s medical products, routine end-product testing alone is often not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end-product testing does not reveal variations…
COURSE OUTLINE ISO 13485:2016 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services. Medical Devices are products designed to cope with disease, treat injuries, investigate and augment human functions and they also are made up of a host of other apparatuses and…
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
In-Vitro Diagnostic Medical Device Directive (98/79/EC) – CE Marking
EU Medical Device Regulation (MDR 2017/745)
US Quality System Regulation (21 CFR Part 820)
Japan Quality Management System (J-QMS Ordinance)
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 (AMDD) for Importer
Creation of Common Submission Dossier Template (CSDT) for manufacturer according to ASEAN MDD (AMDD)
Creation of Technical Documentation according to European Medical Device Directive (93/42/EEC)
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 ASEAN MDD, EU MDD/MDR, US FDA
Product modification strategies and management
US FDA Warning Letter Resolution