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:

Wearable Medical Device Projects

Motion Control Projects

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

Liquid Biopsy Platform

Wearable for Medical Eye Care Procedure

System Design

Software and Firmware

Wearable for Sleep Analysis

Voler Provides Solutions

“I want to state again how unbelievably reliable this new product has been. In 30 years of medical devices, and 13 in OTC devices, I have never heard of any with better than a 1-2% DOA/infant failure rate, and I understand that the device is doing considerably better than that. Especially considering the technological sophistication of the product, I am sure it is some sort of record, if this information were routinely public. I know that even one or two failures in a downline are very uncomfortable for a consultant, but with fast replacement we should be able to keep everyone happy. Thanks” – Bob




Interested in Learning More? Contact Us Today!


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