Medical Device Design Consultant
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.
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 devices development and design capabilities by delivering quality products:
Personalized Healthcare Development Through Wearable Sensors
Wearable Medical Device Product Development
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:
- Wearable Medical Device Design Specialists
- Secure-by-Design Medical IoT and Wearable Devices
- A Comprehensive Slide Presentation of Wearable Device Sensors Since 2017
- Advancing Stroke Rehabilitation: Breakthrough Device Enhances Patient Recovery and Mobility
- Biosensors: Avoiding Errors Measuring Physiological Functions like EKG, Heart rate, and Temperature
- Are You Making a Medical Device?
- Voler Whitepaper: Developing Product Requirements for Medical Devices
- Sensor Calibration Verifies Accuracy
- Blog: Medical Devices
How We Design Next Phase Medical Devices
Medical Devices FAQs
Questions About Our Medical Device Services?
What does a medical device design company like Voler Systems provide?
As a trusted medical device design company, Voler Systems offers complete support for medical device product development, including electronics, embedded firmware, sensors, wireless communication, and regulatory-focused engineering. Their team helps businesses move from concept to manufacturable products efficiently.
Why should companies hire a medical device design consultant?
A medical device design consultant helps reduce technical and regulatory risks during development. Voler Systems supports Medtech companies with design planning, risk analysis, verification testing, and engineering expertise for Class I through Class III medical devices.
How does Voler Systems support medical device product development?
Voler Systems delivers end-to-end medical device product development services, from prototype creation and sensor integration to embedded software and manufacturing support. Their multidisciplinary engineering team focuses on performance, reliability, and scalability.
What types of medical devices development projects does Voler Systems handle?
Voler Systems works on a wide range of medical devices development projects, including wearable healthcare devices, heart pumps, biopsy systems, neurological devices, and remote patient monitoring technologies. Their experience spans multiple regulated Medtech sectors.
Can Voler Systems work as medical device consultants alongside internal teams?
Yes. Voler Systems provides flexible engagement models where their medical device consultants can either manage the entire project or collaborate directly with in-house engineering and quality teams to accelerate development timelines.
What makes Voler Systems a strong Medtech development partner?
Voler Systems combines decades of Medtech expertise with advanced capabilities in wearable technology, ultra-low-power electronics, wireless systems, and embedded software. Their engineering approach helps companies create innovative products that are easier to manufacture and scale.
How does Voler Systems help companies develop next phase medical devices?
Voler Systems supports next phase medical devices by integrating modern technologies like wearable sensors, AI-ready electronics, wireless connectivity, and cloud-enabled monitoring systems. Their engineers focus on future-ready solutions that improve patient care and product performance.