MEDICAL DEVICE Development

We help companies build innovative medical devices

CONTACT US

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 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

Related:

Recent Medical Device Projects

Voler delivers quality products on time and on budget.

altergSystem Design

human heart modelProof-of-Concept Design

liquid biopsy platform

Liquid Biopsy Platform

Software and Firmware

“I want to state again how unbelievably reliable this new product has been. In 30 years of medical devices, and 13 in OTC devices, I have never heard of any with better than a 1-2% DOA/infant failure rate, and I understand that the device is doing considerably better than that. Especially considering the technological sophistication of the product, I am sure it is some sort of record, if this information were routinely public. I know that even one or two failures in a downline are very uncomfortable for a consultant, but with fast replacement we should be able to keep everyone happy. Thanks” – Bob