MITA Continues To Omit In Its Proposed Servicing Standard

MITA continues to omit in its proposed Servicing Standard device manufacturer responsibility to provide appropriate documentation for technical descriptions, instructions for use and preventive and corrective maintenance and repair procedures, despite ANSI/AAMI EQ56: 2013.

IAMERS after receiving a copy of the latest version of MITA’s servicing standard, notified MITA that the Standard continues to impose on ISOs installation, preventive maintenance, complaint and control of design change provisions while omitting concurrent manufacturer responsibilities to provide information necessary to carry out these responsibilities if the standard was to be imposed.

See the May 31, 2017 letter from IAMERS General Counsel below.

IAMERS Letter to MITA

EXCERPTED MITA SERVICING STANDARD

This entry was posted in Business, Government, Healthcare. Bookmark the permalink.

Comments are closed.