After identifying several areas for improvement in a small venture-funded Medical Device company, an electronic Quality Management System (eQMS) implementation was initiated. The best package for the organization was selected, system configuration was defined and documented, and the system was fully validated including to 21 CFR Part 11 requirement for electronic records & signatures. The implementation was well-received across the organization, as it not only improved compliance, but also provided great efficiency gains in the areas of: Document Control, Design Change Control, Training and Supplier Management.
Quality System Integration
As part of merger between two complimentary Medical Device companies, an approach to integrating multiple distinct Quality Systems with shared services was undertaken. Common processes across the multiple QMS were standardized and links established to allow for efficiencies and best practices to be leveraged, while also allowing distinct business units to continue operating in their own way.
Risk Management Overhaul
A small Medical Device company needed to overhaul it's risk management process in order to properly identify risks and benefits associated with its devices, be able to present a cohesive picture of product risk to auditors and reviewers, and meet the compliance requirements of ISO 14971 in support of CE marking of the company products. A system was constructed utilizing simple tools such as Excel, validated to ensure proper performance, and implemented as part of a new product launch. The system subsequently presented very well in support of submissions and external audits.
Complaint System Improvements
A late-stage startup found itself in a situation where customer complaints were not being handled in an efficient and effective way, making it difficult to use this valuable feedback for identifying product improvements and to meet compliance requirements. A complete system overhaul was performed, implementing a closed loop system which also fed quality metrics in order to inform product improvements. Readily available tools such as Microsoft SharePoint were utilized to create a system that was right-sized for the organziation yet also highly compliant to standards.