Horizon Product Development

Consulting and Design Services

Our Services

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We offer consulting and solutions to assist with the complicated process of designing medical devices.  Use our experience to find solutions to technical and compliance issues that arise during the product development process.  We have been involved in the development of dozens of medical devices including software controlled electrosurgical generators, battery-operated disposalbe products and ESU accessories. Let our experience provide solutions to keep projects on schedule and save money by avoiding common mistakes and assumptions.  The medical device market is constantly changing, stay ahead of the curve!

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Design and Development

We offer the following Design and Development Services:

  • Mechanical Engineering
  • Electrical Engineering
  • Prototyping
  • Test Fixtures
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Project Documentation

We work with customers to fulfill quality system requirements to ISO13485 including specific customer requirements.  Services include:

  • Device Requirements / Specifications
  • Project Planning and Scheduling
  • Construct / Update Design History Files
  • Assist with Risk Managment Process / Files per ISO14971
  • Usability Engineering Process / Files
  • Assist with Software Lifecycle / PEMS Per FDA Requirements
  • Assist with 510K files for submission
  • Solid Modeling / 2D drawings
  • RoHS Review
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Verification Testing

We provide verification testing to required medical device standards.  Product requirements are reviewed and verification testing is developmed to meet device specific requirements.  Can work with external testing agencies to communicate customer's need for EMC, Safety, Usability, Software / PEM.

Particularly experienced in the following standards: 

ANSI/IEC 60601-1:2005 3rd Edition

ANSI/IEC 60601-2-2:2009

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