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

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

Medical Device Design, Deveopment and Validation