About Us

Biopass Medical Systems located in Coral Springs Florida is a contract Medical Device Engineering firm with over 30 years of experience.

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Since 1999 we have developed products for the following companies:

  • Allen Medical
  • Aurora
  • Dental-EZ
  • Hill-Rom
  • Nipro
  • Sentech
  • Smith & Nephew
  • Steris
  • Tridien

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Products developed include:

  • Advanced medication infusion systems
  • Consumer medical and home healthcare devices
  • O.R. patient positioning and temperature control systems
  • In vitro diagnostic devices
  • Infant incubator controllers
  • Low-Airloss and Bariatric sleep surfaces
  • Air-Fluidized beds
  • Surgical drill and shaver systems
  • Orthopedic post-surgical therapeutic devices

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Our ISO 13485 Design Controls include procedures for:

  • Design Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification
  • Design Validation
  • Design Transfer
  • Design Changes
  • Design Life Cycle
  • Risk Management
  • Software Configuration Management
  • Software Level of Concern Reporting
  • Requirements Traceability
  • Completeness and Accuracy Auditing
  • Anomaly Reporting
  • Verification and Validation Summaries
  • Design Changes For Existing Devices
  • Software Release procedures
  • Software Requirements Specifications
  • Design History File