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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
  • Laryngoscopes
  • Catheters
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.
Medical Device Software

Voler wrote all the firmware and software for a heart pump....

Wearable for Medical Eye Care Procedure

This device treats dry eyes by applying heat to the eyelids...

Electronics and Embedded Software for Medical Devices

We provide full-service R&D consulting from concept and...

Liquid Biopsy Platform – A Challenging Design

We have completed a challenging project that started with a...

Voler is an outstanding design team

Delivering a Prototype Project within Set Cost and Timeline...

A Fun & Interesting Project: Anti-Gravity Treadmill

Voler Systems provided two broad services to AlterG: debug...

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