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 our wearable medical device design and development firm for reliable new products and test systems involving sensors and measurement electronics.
Medical Device Development Consultants
Our medical device design and development firm’s multidisciplinary team knows the regulatory process and procedures and delivers high quality products on time and on budget.
Voler has demonstrated these medical device design and development capabilities by delivering quality products:
Wearable Medical Device Projects
Motion Control Projects
System Design Projects Including Software and Wireless Technology
- Laryngoscopes
- Catheters
Proof of Concept Projects
- Proof-of-concept catheter
to measure impedance of heart muscle
Test Equipment
for critical applications such as class 3 medical devices
- Heart valve tester
- Disposable catheters
Regulatory Requirements
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
- FDA update on mobile apps
Related:
- Secure-by-Design Medical IoT and Wearable Devices
- Overview of Wearable Device Sensors
- Motion Control for Medical Devices
- Biosensors: Avoiding errors measuring physiological functions like EKG, heart rate, and temperature
- Are You Making a Medical Device?
- Whitepaper: Developing Product Requirements for Medical Devices
- Calibration Verifies Accuracy in Medical Devices from Embedded Computing Design June 2011
- Blog: Medical Devices
- How we do medical devices
