Design Solutions Inc.
  • Engineering Services
    • Medical Device Design & Product Engineering
    • Electronic Design
    • Software Development
    • MECHANICAL DESIGN
    • Design Verification
    • Regulatory Compliance
  • Benefits
    • Engineering Design Process
    • Medtech Expertise
  • Case Studies
    • Sleep Apnea Screener
    • Contrast Injector System
    • Wireless Event Recorder Device
    • Orbital Athrectomy System
    • Peripheral Artery Disease Measurement System
    • Intra-Compartmental Pressure Monitoring Device
    • First Responder Vital Signs Monitor
    • Impedance Cardiography (ICG) Monitor – Case Study
    • Oximetry Analysis Software System
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ORTIBAL ATHRECTOMY SYSTEM

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TECHNOLOGY: Peripheral arterial disease

Client Need

A start-up customer purchased a prototype design of an orbital athrectomy system from an Eastern European company.  The prototype was functionally for proof of concept but was not designed for manufacturing and did not contain the proper design documentation required for the design history file. 

PROJECT SUMMARY

Design Solutions reviewed the entire design and updated the mechanical, electrical and software of the device and creating proper documentation for manufacturing and FDA submission. This included creation and management of the design history file and regulatory testing for safety and EMC in accordance with IEC 60601.  We completed the design and worked with the clients regulatory group to obtain the necessary approvals and set up the manufacturing at a contract manufacturer by bringing the product through pilot production.  
Customer Project: Orbital Athrectomy System

skills applied:

  • Design
  • Mechanical
  • Electrical​
  • Software
  • Verification
  • Compliance
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a collaborative team partnership

We take pride in our extensive range of services to our clients. Our ISO 13485:2016 certified engineering design process assures our customers
​that we can fulfill their needs at every level of the medical device design and development process.
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SERVICES
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 Verification
 Compliance
BENEFITS
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  • Engineering Services
    • Medical Device Design & Product Engineering
    • Electronic Design
    • Software Development
    • MECHANICAL DESIGN
    • Design Verification
    • Regulatory Compliance
  • Benefits
    • Engineering Design Process
    • Medtech Expertise
  • Case Studies
    • Sleep Apnea Screener
    • Contrast Injector System
    • Wireless Event Recorder Device
    • Orbital Athrectomy System
    • Peripheral Artery Disease Measurement System
    • Intra-Compartmental Pressure Monitoring Device
    • First Responder Vital Signs Monitor
    • Impedance Cardiography (ICG) Monitor – Case Study
    • Oximetry Analysis Software System
  • About Us
    • Management Team
    • News
    • Events
  • Contact
  • Get Started