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Market Focus
- Health Management – EHR, PHR, HIPAA
- Medical IOT (MIoT)
- Point-of-Care Diagnostics
- Laboratory Diagnostics
- Life Support
- Drug Delivery
- Hearing Aids
- Patient Monitoring
- Cardiovascular
- Respiratory
- Imaging
- Endoscopy Cameras
- Scientific & Industrial Instrumentation
- Wearables
Market Focus
- Health Management – EHR, PHR, HIPAA
- Medical IOT (MIoT)
- Point-of-Care Diagnostics
- Laboratory Diagnostics
- Life Support
- Drug Delivery
- Patient Monitoring
- Cardiovascular
- Respiratory
- Imaging
- Wearables
- Hearing Aids
- Endoscopy Cameras
- Scientific & Industrial Instrumentation
Medical device design engineering services
- Product Design
- Subsystem design
- Technical file for regulatory and certification submission as required by FDA (510(k), DeNovo etc.) and CE
- A key specialty is guiding companies to deliver software work products that are required by regulatory bodies such as FDA and CE with emphasis on IEC 62304, HIPAA and the 2022 draft guidance for Cybersecurity in Medical Devices
- Process Efficiency
- Focus on client value
Disciplines
- Project Management
- Requirements & Risk Management
- QMS
- V&V
Disciplines
- Studies
- Builds
- Manufacturing transfer
- Regulatory submission
- Product Certification
How We Do It
Systematic design engineering approach
Refined in collaboration with 200+ clients and 450+ projects
Time-tested project management & client communication methods
- Serve to streamline the overall design process
The right Engineering questions asked and answered
- Early – before it gets expensive
We have a world-class, multi-disciplinary Engineering Team
- Extendable to meet project requirements
- Cross-disciplinary to serve needs into transfer to manufacturing
How We Do It
Systematic design engineering approach. Refined in collaboration with 200+ clients and 450+ projects.
Time-tested project management & client communication methods
- Serve to streamline the overall design process
The right Engineering questions asked and answered
- Early – before it gets expensive
We have a world-class, multi-disciplinary Engineering Team
- Extendable to meet project requirements
- Cross-disciplinary to serve needs into transfer to manufacturing
Our Core Team Experience
We’ve pretty much seen it all over the years and know the most efficient development path for your device.
Years of Combined Experience
0
+
Projects COmpleted
OVER
0
+
Let us bring this wealth of experience to bear on your device development.
The Value We Bring to Our Clients
- Speed up time to market by drastically reducing physical design iterations
- Take the guess work out of your design development process
- Provide a reliable, robust engineering solution that works consistently
- Eliminate Wishful engineering
- Specifications and virtual design iterations yield robust physical designs
- Will Work designs that scale easily as opposed to Can Work devices that fail at scale.
- Get you to where you need to be efficiently
