The medical device design and development process is a critical part, and is fundamental in order to check for design flaws, usability improvements and proper function.
During the design phase, Gard Consulting develops design and process specifications, risk analysis, FEA analysis with dedicated in vitro and in vivo test protocols with product-specific testing equipment. A marketable medical innovative device must have the safety and also reliability features necessary in order to pass Notify Bodies inspection.
Gard Consulting follows the Design Control process and knows and applies the ISO standards.
Gard Consulting conducts and documents the activities with the required level of quality in order to head to premarket with everything needed to get the device approved.