Our services for you
We are supporting customers in different phases of product development and product lifecycle - always dependent on customers needs.
Our clients know their products better than we do.
Therefore, product design is not our business but we are highly experienced providing all accompanying services needed for successful product approval, regulatory compliance for all medical device risk classes and lifecycle management.
Please find below examples of projects we have realized during the last years.
Project Examples | Design Control | Risk Management | Regulatory & QMS | Clinical Evaluation | Design Transfer | Usability Engineering | Project Management |
Cataract Surgery IOL Injector | |||||||
Respiratory / Ventilation Anesthesia Workstation | |||||||
Neurosurgery Liqor Drainage | |||||||
Endoprosthesis Bone Cement Applicator | |||||||
Cardiac Surgery Heater Cooler Units | |||||||
Surgery Pulse Lavage | |||||||
IVD Flow Cytometry | |||||||
IVD Photonic Diagnostics | |||||||
Neurosurgery Brain Access Ports | |||||||
Combination Products Powder Instillation | |||||||
Combination Products Powder Inhaler | |||||||
Combination Products Pen Injector | |||||||
Cleaning and Disinfection Endoscope Reprocessing | |||||||
Imaging MRT Contrast Media Injector | |||||||
Drug Delivery Perfusor | |||||||
Healthcare Software Rehabilitation App | |||||||
Sensor Technologies Embedded Systems | |||||||
Pharmaceuticals Production Relocation | |||||||
Intensive Care Ventilator GUI Design | |||||||
Diagnostics Non-invasive Blood Diagnostic | |||||||
Design Control | Risk Management | Regulatory & QMS | Clinical Evaluation (*) | Design Transfer | Usability Engineering | Project Management |
(*) Performance Evaluation for IVD