Recent FDA findings reveal that out of 582 firms audited, 32% had potential design control deviations. Our knowledge and expertise enables us to successfully present technical information to reviewers and auditors from FDA and other regulatory bodies. We provide the planning, design, and quality documentation necessary to assure successful regulatory submissions throughout world.  Depending on regulatory needs, we can provide engineering services under customer specified design controls or our design controls.   We work with your regulatory staff to ensure the delivered documentation package seamlessly integrates into your DHF and regulatory submissions.

Our design controls include procedures for:

Design Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Life Cycle
Risk Management

Software Configuration Management
Software Level of Concern Reporting
Requirements Traceability
Completeness and Accuracy Auditing
Anomaly Reporting
Verification and Validation Summaries
Design Changes For Existing Devices
Software Release procedures
Software Requirements Specifications
Design History File