Looking for a medical device consultant?
We help companies build innovative medical devices
Speed up your product design without sacrificing quality by using our experienced project management and rigorous design methodology. Take advantage of our impressive track record of first-time-right designs.
Deep and Wide Technical Expertise
Entrust your product design with Voler’s expert medical device design team – combining decades of digital design experience on hundreds of projects across a wide spectrum of medical devices including human use devices.
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
Improve your competitive advantage and streamline the entire product lifecycle – from concept and design through to production and sustaining engineering – by taking advantage of Voler’s tightly-knit partnerships with Industrial Design, Mechanical Engineering and Manufacturing partners.
Flexible Engagement Models
Our team can take on complete responsibility for all aspects of development, or we can share the responsibility with your in-house team.
Recent Medical Device Projects
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
The Engineering Team that delivers
Voler Systems specializes in providing full service electronic design services, from concept and design through to production and sustaining engineering. We have completed hundreds of projects over 17 years. Accelerate your time to market by partnering with our multidisciplinary team of 30+ experts.
Product development • Sensors • Wireless • Motion Control • Embedded Systems • System architecture • Firmware development • Board Design • Analog design • Power supply design
Medical devices • Home Health • Wearables • Industrial automation • Power and green energy • Consumer electronics
AREAS OF MEDICAL DEVICE DESIGN EXPERTISE:
Wireless • Motion control systems • System design • Proof of concept design • Software • Embedded firmware • Low-power design • Testing and verification • Catheter • Heart pump • Endoscopes • Laryngoscopes • Heart valve tester