ORTIBAL ATHRECTOMY SYSTEM
TECHNOLOGY: Peripheral arterial disease
Client NeedA start-up customer purchased a prototype design of an orbital athrectomy system from an Eastern European company. The prototype was functionally for proof of concept but was not designed for manufacturing and did not contain the proper design documentation required for the design history file.
PROJECT SUMMARYDesign Solutions reviewed the entire design and updated the mechanical, electrical and software of the device and creating proper documentation for manufacturing and FDA submission. This included creation and management of the design history file and regulatory testing for safety and EMC in accordance with IEC 60601. We completed the design and worked with the clients regulatory group to obtain the necessary approvals and set up the manufacturing at a contract manufacturer by bringing the product through pilot production.
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