Electronics and Embedded Software for Medical Devices
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
Our clients, big and small, are delighted with our service.
Clients who trust us
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Upgrades on Medical Device Design Capacities | Voler Systems
Voler announced today that it is expanding current medical device design capabilities...