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.