When required, test methods can be validated within a Quality Management System to ensure compliance with ISO 13485 (MDR) for medical devices. Depending on the phase of development, compliance to ISO standards can be applicable.
A variety of analyses can be provided:
Conceptualization
Plan
Design & Development
Prototype
Conceptualization
Plan
Design & Development
Prototype
Validate
Technology Transfer
Manufacturing
Validate
Technology Transfer
Manufacturing
