Spoken mostly in the realm of medical device development, we feel that risk mitigation and quality management are best practices in engineering regardless of industry. We have developed an efficient and comprehensive QMS that is compliant with FDA 13485 standards. Throughout device development we ensure that proper inputs and device specifications are documented.
Our design outputs are verified with respect to these inputs and serve as the foundation for subsequent iteration. In many cases we manage the design history file for our clients. In other cases we supplement their documentation file with the necessary engineering and regulatory documentation. We view dFMEA and other risk assessment techniques as design tools that should be used throughout engineering refinement.
Output from these risk sessions feed the implementation of safety features, controls, materials, and other details that mitigate risk while meeting standards of safety and effectiveness. We also evaluate risk from the development perspective, illuminating potential issues before they arise, and building contingency plans to ensure that the project stays the course.
Competencies
- Design Controls Development
- dFMEA
- Purchasing & Inspection Control
- 2D Engineering Documentation
- Design History File Management
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