We provide full-service R&D consulting from concept and design to production of devices for human use and instruments. Our multidisciplinary team knows the regulatory process and procedures and delivers high-quality products on time and on budget.

Voler Systems can design to 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 – Quality System Regulations
 Firmware for a surgical table

Firmware for a surgical table

Wireless communication

Wireless communication

 Firmware for a surgical table

Heart Pump

 Firmware for a surgical table
 Firmware for a surgical table
Wireless communication

Past Clients – Our clients, big and small, are delighted with our service.