Specialists in Medical Device Development and Manufacturing

We offer a comprehensive turnkey solution for developing medical device products for our clients, from concept through to manufacturing transfer.

Integral to our product development services is our attention to quality and design control. The design control process is part of our ISO 13485 certified Quality Management System. The process is focused to ensure we capture the requirements and priorities of our customers.

As a project-oriented company we assemble product development teams with the skills and knowledge specific to each new product.

• Turnkey product development solutions
• Technology development
• Product conceptualization
• Industrial design
• Mechanical engineering
• Electrical engineering
• Engineering physics
• Software design

• Market needs evaluation and user studies
• Competition analysis
• IP analysis and development
• Requirements capture
• Product definition

• Regulatory strategy
• Quality planning
• Verification
• Validation and clinical testing
• Regulatory submissions USA, Canada, Europe
• Product safety testing

• Detailed design
• Prototyping
• Manufacturing transfer