Quality Management System & Regulatory Compliance

Systems:

·         Quality Management System (QMS) and all its associated subsystems (QSR, ISO 9001, ISO 13485, MDD, CMDR)

·         Risk Management (ISO 14971) (safety and enterprise risk)

·         Environmental Management System (ISO 14000)

·         Quality and Regulatory organizational structure and development

Processes:

·         Product development and commercialization process (hardware, software and systems)

·         Effective Management Reviews

·         Quality System Training and Effectiveness

·         Quality System Audits

·         Quality Planning

·         Closed loop CAPA System

·         Failure investigation and Root Cause Analysis

Products:

·         510(k) Submissions, Establishment Registration and Device Listings

·         Technical File and CE Marking (MDD, EMC and Low Voltage Directives)

·         Risk Analysis (FMEA, FTA and HA)

·         New product Quality Planning (V&V and RDT planning and execution)

·         Sterilization

·         Biocompatibility and material selection

To sign up or to get more information, please contact LSS at: 

QMS@STG-ENG.com

Or Call us : (858) 382-1864



Clinical Audit
 
The systematic critical analysis of the quality of medical care including the procedures used for diagnosis and treatment, the use of resources and the resulting outcome and quality of life for the patient.

The clinical audit lead has a clear role in creating the strategy for embedding clinical audit within the organisation, but the individual chosen must have more than just a nominal strategic role. The clinical audit lead should have a high profile within the organisation, and must champion clinical audit both to colleagues and management alike. The clinical audit lead should be actively involved in linkages to the other aspects of clinical governance to allow for the dissemination of clinical audit information and the setting of local clinical audit priorities.

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