Industries / Medical Devices

We help companies build innovative medical devices

We provide full-service R&D consulting from concept and design to production of medical devices for human use. Since 1979, clients have turned to our wearable medical device design and development firm for reliable new products and test systems involving sensors and measurement electronics.

Medical Device Development Consultants

Our medical device design and development firm’s multidisciplinary team knows the regulatory process and procedures and delivers high quality products on time and on budget.

Voler has demonstrated these medical device design and development capabilities by delivering quality products:

System Design Projects Including Software and Wireless Technology
Proof of Concept Projects
Test Equipment

for critical applications such as class 3 medical devices

Regulatory Requirements

Voler Systems meets the strict requirements for federal and European design that include:

  • IEC60601 – medical device requirements
  • IEC62304 – medical device software
  • FDA 21CFR 820.30 Quality System Regulation – Design control
  • ISO 13485:2003 quality management systems – requirements for regulatory purposes
  • FDA update on mobile apps

Recent Medical Device Projects

Voler delivers quality products on time and on budget.
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Voler is really good at identifying risks and finding the best way to do a project on-time, on spec, and easy to manufacture.