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Medical Device Design Consultant

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.

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 devices development and design capabilities by delivering quality products:

Personalized Healthcare Development Through Wearable Sensors



Wearable Medical Device Product Development
Motion Control Projects
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

How We Design Next Phase Medical Devices


Recent Medtech & Medical Device Projects

Voler delivers quality products on time and on budget.
Heart Pump Console Software Passes FDA Review with Zero Conditions, Facilitating Faster Path to Clinical Trials

Company: Fortune 500 Medical Device Company Industry:...

Transforming a Dry Eye Treatment Prototype into a Market-Ready, FDA-Approved Wearable Medical Device

Company: Eye Care Technology Company Industry: Medical...

Electronics and Embedded Software for Medical Devices

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

Revolutionizing Early Lung Cancer Detection with Advanced Liquid Biopsy Device Development

Company: Guangzhou EZLife BioSci Tech Co. Ltd Industry:...

"Voler is an Outstanding Design Team"

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

Gravity-Defying Success: FDA Approval Journey of an Innovative Anti-Gravity Treadmill

Company: AlterG Industry: Medical and Consumer Products Use...

Interested in Learning More? Contact Us Today!