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Biomedical Devices Services

BMDK pools its large resource base consisting of the parent company, offshore centers and partners to provide engineering services in the following areas:

Contract Manufacturing

BMDK specializes in assembling electro-mechanical devices as well as sterile,
single-use accessories. For your convenience we offer:

  • In Process Electrical/Electronic Testing
  • Controlled Environment Assembly Room
  • Final QC Inspection
  • Storage and Warehousing Engineering

Analysis and Design

  • 3-D Modeling
  • Finite Element Analysis
  • Thermal Analysis and Heat Transfer
  • Prototyping
  • Detail Engineering

Medical Electronics Engineering

  • Digital and Analog Circuit Design
  • Hardware Design
  • PCB Layout
  • Power Electronics Short-Range
  • Wireless Systems
  • Sensors and Imaging Technology

Software Development

  • System Analysis and Design
     • Embedded Application
     • Database Oriented Design and Development
     • Wireless Application Design and Development
  • Integration
  • Testing
  • Implementation

QA and Regulatory Services

We are registered and qualified with the FDA as a Medical Device Establishment. Our Quality System complies with FDA and follows the spirit of the ISO 13485 standard. We provide following services to other medical device companies and start-ups:

  • 510(K) Assessment
  • Development of Written Argument for Substantial Equivalence
  • Identify Applicable FDA Guidance Documents
  • Prepare and Submit 510(K)
  • Develop IDE application
  • Assistance Throughout PMA Process

Biomedical Devices of Kansas News

CURRENT HAPPENINGS

Biomedical Devices of KS invites you to join us at these industry events. Click here to find where.

PRESS RELEASES

December 11, 2008
Biomedical Devices of Kansas expands into Medical Device Refurbishing and Servicing Industry. Read Press Release.

 

December 4, 2008
Biomedical Devices of Kansas announces an Environmentally Controlled Room as part of its future capabilities.
Read Press Release.



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