Our PROCESSES
Quality
We have a comprehensive quality management system, ISO 13485 certified and compliant with FDA requirements. Our quality system is flexible and can be used stand alone, or in conjunction with yours .
Risk Analysis
Our Risk Management starts with being ISO 14971 compliant. We perform risk analysis, risk evaluation, risk mitigations, and residual risk assessment. Conducting activities from hazard analysis through FMEA, we ensure your device meets its requirements.
Development Model
Our development model starts with your program requirements and follows specific tasks designed to minimize program risk and maximize output. With this model we can work independently or in tandem with client teams.
Verification & Validation
Through our verification and validation process, we will ensure that the performance of the product will meet your specifications and the requirements of both regulatory agencies and your customers.
Prototyping
From proof of concept through production equivalent devices suitable for verification and validation activities, we can supply prototypes utilizing 3 D printing, rapid turn PCBs and fully functional software.
Transfer to Manufacturing
We can assist with supplier selection per criteria we develop or receive from you, and transfer product design output to approved contract manufacturers, as well as provide production support.