Medical Device Design Engineers
We provide full-service R&D consulting from concept and design to production of devices for human use. Since 1979, clients have turned to us for reliable new products and test systems involving sensors and measurement electronics. Our multidisciplinary team knows the regulatory process and procedures and delivers high quality products on time and on budget.
Voler has demonstrated these capabilities by delivering quality products on time and on budget:
‘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