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 Wearable for medical eye care procedure Wearable for sleep analysis Motion Control Projects Three Motion Control Medical Devices System Design Projects Including Software and Wireless Technology Heart pump Liquid biopsy platform Endoscopes 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: 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 Recent Medical Device Projects Voler delivers quality products on time and on budget. A Fun & Interesting Project: Anti-Gravity... Voler Systems provided two broad services to AlterG: debug and... Voler is an outstanding design team Delivering a Prototype Project within Set Cost and Timeline "We... Liquid Biopsy Platform – A Challenging... We have completed a challenging project that started with a... Electronics and Embedded Software for Medical... We provide full-service R&D consulting from concept and design to... Wearable for medical eye care procedure Device to treat dry eyes was successfully put on the...