Medical Technology

Juraj Žoffčák
Swimmer and Service Unit Leader
Medical Technology
How do I master digital change in Medical Technology
better ask ERNI
Our fields of activity include:
In Vitro Diagnostics (IVD) / Clinical Chemistry IVD / Molecular Diagnostics / Sequencing
Development Process Optimisation Consulting
Point of Care Solutions
Laboratory Workflow Automation
Diagnostics Data Analytics
- Embedded software development for instrumentation
- Software application development for data management
- Formal Verification & Validation using BSL-certified laboratory facilities
- Outcome-based Software Delivery Services (Managed Services) applying ISO 13485-certified software lifecycle processes
- Regulatory compliance consultancy services (ISO 13485, FDA 21 CFR, GxP)
- Process design and documentation following regulatory requirements
- Software development process optimization considering regulatory requirements such as traceability management, electronic records and document management
- Software development tool evaluations considering regulatory aspects
- Software application development for connectivity and data management
- Product innovation management
- Sample workflow automation
- Inventory control
- Cloud solutions and cloud testing
- LIS/HIS connectivity
- Instrument driver development
- Order management
- Automated testing
- Outcome-based software delivery services (Managed Services)
- Machine Learning and Data Analytics to generate added value for the business
- Artificial Intelligence: infusing AI into existing apps
- Cognitive Services
- IoMT
- Image, voice and information gathering added to logistics app
- Preventive & predictive maintenance solutions
Industry sectors
Banking & Insurance
Professional Services
Government
Medical Technology
Transportation & Logistics
Manufacturing