We deliver safety focused solutions for complex medical devices in critical care, defibrillation and monitoring.
Project Security
High level of critical care safety expertise and experience from over 300 long term projects
Quality & Innovation
High end devices for the smallest platforms with latest market insights & innovative modules
Ready for Market
Designed & tested for the best market fit, with full technical documentation making devices ready for regulatory approval.
Expedited & Cost-Effective
Automated testing, immediate improvement as well as Licensing & Sharing of IPs to reduce development time and costs.
Paving the way for new medical devices and regulatory support for all global markets.
Development
Creating complex medical devices or costumized modules
- Finding best product market fit
- Process designed to get ready to market
- Develop high end medical solutions
- Experienced integration team
- Saving development costs with our modular system
- Network of experts to overcome challenges
Overview Development Services
- Hardware:
PCB Layout, Controller, Housing, Sensors, Prototyping, Mass Production design - Software:
Embedded System Platform, Connectivity ECG Algorithms, System Architecture - Functional safety:
Automated Testing, EMC
Consulting
Making Regulatory Affairs as efficient as it gets
- Regulatory Approval service
- Easier from NMPA to CE or FDA approval
Getting your devices equipped with the right technology
for best market fit
- Support & reviews to fit product requirements
- Expertise in high voltage & vital signs sensors
Overview Consulting Services
- QM/RA:
Gap analyses for technical documentation, approval support MDR / FDA, ISO 13485 compliant QM system - R&D:
System footprint workshop, proof of concept, cyber security, automated testing, ECG customization & software algorithms
Modules & Licences
Proven Modules & Integration of renowned, high tech sensors
- Modules in over 100k devices around the world
- Integration expertise for high tech HW/SW modules
- Own solutions for Defibrillation & Monitoring (see below)
- All modules available as licence
- Shareable IPs for from various innovative projects
Shock360
Defibrillation board with pacemaker option and up to 360J for AEDs & Defibrillators.
CAP201
Precise sidestream capnography module for emergency, clinic & MRI
Push
Plug and play CPR Feedback solution to upgrade your defibrillator, AED or monitor.
We licence and share our know-how! Take a look at some of our previous developments and see what we have to offer for your medical device project.
OOONO – World‘s Smallest AED
- AED as Consumer Product
- Striving for highest effectivity in smallest size
- Hardware / Software
- Safety electronics
- Customized ECG Algorithms
- Reliable Powermanagement
- Lower production costs
FDA Approved Bloodpressure Monitor
- Embedded System Platform
- SpO2 / Temperature
- Powermanagement
- Connectivity
MDR Ready Defibrillator & Monitoring Device
- Hardware / Software
- Development
- Embedded System
- ECG, SpO2, NIBP, CO2
- Life cycle management
MDR Ready ECMO mobile therapy device
- System architecture
- Software development
- Safety electronics
- Customized ECG Algorithms
- Alarm systems
Get in Contact with our Sales Team or book an appointment with our head of Sales.
Christian Fischer
Head of Sales
