Technical Services Listing

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Product Development

We offer a number of value-added services in support of early product development activities:

• Customer needs identification/Voice of Customer
• Brainstorming
• Concept development
• Prototyping
• Technical review
• Cost reduction

Design Control

Our staff can support any aspect of your design control activities, whether your product is a disposable therapeutic device or a capital equipment diagnostic device:

• Design and development planning
• Requirements development (Design Input)
• Specification development (Design Output)
• Design verification
• Design Validation
• Design transfer, including process validation (IQ/OQ/PQ)
• Design review
• Risk analysis
• DHF and DMR development and gap analysis
• Design control policy and procedure development
• Design control process improvement
• Design control training

Quality Assurance

We provide quality assurance services with a difference—most of our quality professionals have product development engineering backgrounds to assure maximum effectiveness in working with your staff:

• FDA Quality System Regulation (QSR) compliance
• ISO13485 compliance
• CAPA compliance
• Pre-inspection mock audits
• Risk management
• Quality system gap analysis
• Quality manual development
• Validation

Regulatory Affairs

We can handle all types of regulatory submissions and filings, as well as assisting in dealing with regulatory problems:

• 510(k)
• IDE
• PMA
• Technical files
• Design dossiers
• 483s
• Warning letters
• ISO Audit Response

Manufacturing

We provide services to support manufacturing:

• Design for Manufacturing (DFM)
• Lean Manufacturing
• Cost reduction
• Statistical Process Control (SPC)
• Process Validation (IQ/OQ/PQ)
• Quality Control

Project Management

We can provide the help you need to assure that your projects will achieve results on time and on budget:

• Project management process
• Communication
• Team management

Expert Witness

We can provide expert technical witnesses for many types of medical devices.

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