QECS offers comprehensive support to medical device companies in the areas of FDA quality system regulation (QSR) and ISO compliance for medical device companies.Design ControlsWe develop and implement design controls for manufacturers of medical devices, including IVDs (in vitro diagnostics), biologics, and combination products under ISO 9001/ISO 13485 and FDA's quality system regulation (QSR).Our consultants have worked with Fortune 100 through start-up manufacturers, assisting with establishment of design controls through conducting audits and "rescue" efforts. We scale the quality system effort to the needs of the company, its products, and its culture.How NAMSA Can HelpDesign control procedures and implementationDesign control auditsDesign development planDesign control project managementDMR (device master record)Risk management program development and implementation per ISO 14971:2007Risk Management Plans and ReportsRisk analysisFailure modes and effects analysis (FMEA)Fault tree analysis (FTA)Preliminary hazard analysis (PHA)Health hazard evaluation (HHE)Medical Device product design history file complianceBiocompatibility and sterilization assessmentMedical device standards assessmentProcess validation (IQ/OQ/PQ)Change controlQuality SystemsNAMSA develops and implements quality system and compliance strategies for manufacturers of medical devices including IVDs (in vitro diagnostics), biologics, and combination products. We assist clients in a variety of ways including quality system implementation, pre- and post-market compliance activities, risk management, and medical device product design control support.How NAMSA Can HelpAdvisory and consultative support (hourly)Full system implementationAuditsOn-site staffingFunctioning as a virtual departmentEmergency responseFDA interactionsWe commonly help large medical device manufacturers with tasks such as these:Improve or correct non-compliant quality system procedures,