Bringing your product to market

Our team of engineers has aided customers in the Medical Device space with product design, reliability enhancement, risk management, software validation, test, and quality management. We have experience with designing, validating, and producing documentation for Premarket Approval of Class I, II, and III devices.

Our medical device customers appreciate the value that we add to their product development in areas such as:

• Electronics design
• Software development in accordance with IEC 62304
• Risk management to ISO 14971
• Quality planning and ISO 13485
• Design for reliability, reliability analyses, reliability testing
Safety & hazard analysis & documentation for Premarket Approval (PMA)

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Product lifecycle development

Below is a sample of our experience. Contact us for more details.
Planning
  • Quality planning and ISO 13485
  • Risk management and ISO 14971
  • User requirements
  • Design architecture
  • Analysis of alternatives, trade studies
  • Simulation/modeling
  • Project planning
  • Gap analysis
Design
Development
Testing
Manufacturing
Operating & Support

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