Product Development

We help you develop new medical devices from beginning-to-end by providing turnkey product development services. We develop your product through our established development process that includes:

• Project Planning
• Concept Design
• Detail Design
• Design Verification
• Design Validation
• Design Transfer

We deliver the documentation and resources required for you to manufacture your medical device and take your product to market. Our deliverables include:

• Test Reports & Development Records
• Design & Manufacturing Related Files
• Product Tooling & Equipment
• Approved Supply Chain
• Controlled Lab Notebooks
• Project Communication Records

These items are packaged in an FDA-required organization and delivered to you when the product is transferred to production. We deliver the following FDA-Compliant records:

• Design History File (DHF)
• Device Master Record (DMR)
• Device History Records (DHR)