Design Control

Veracord is experienced in leading efforts to establish and implement a system for design controls for various classes of medical devices for the U.S. and international markets. We can lead your organization through the entire design control process including program design and implementation:

• Design Input
• Design Output
• Design Review
• Verification
• Validation
• Design Transfer
• Design Changes
• Design History File
• Design Control Policy and Procedure Development
• Design Control and Process Improvement
• Design Control Training

Quality Assurance

Veracord provides a variety of Quality Systems services geared to meet client and regulatory requirements. Some of our proven robust services include:

• Quality Manual Development
• QSR compliance
• ISO 13485: 2003 compliance
• ISO 9001: 2000 Compliance
• ISO 11607: Test Method Validation
• CAPA compliance
• FDA mock audits
• Risk management
• Gap Assessment

Regulatory Affairs

Veracord’s team of professional experts is composed of former FDA reviewers and leading experts from standards organizations, notified bodies, and industry. Areas of expertise include:

• Investigational Device Exemption (IDE) Applications
• Pre-market Notifications [510(k)s]
• Pre-market Approval (PMA) applications
• Master Files
• FDA 483s and Warning Letter Response Development
• ISO Audit Response
• Consent Decree
• Product Recalls

Manufacturing

Veracord benefits clients by providing manufacturing guidance, support and optimization services:

• Design for Manufacturing (DFM)
• Lean Manufacturing
• Statistical Process Control (SPC)
• Verification
• ISO 9001: 2000 Compliance
• Process Validation (IQ/OQ/PQ)
• Quality Control