Nationwide hosts IAMERS forum on QMS in advance of FDA report

Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill.

See the full story at DOTmed by clicking here.


IAMERS team visits FDA as a follow up to New Orleans Annual Meeting

Supreme Court Ruling Reignites ‘Right to Repair Debate’

Read the AAMI article here.


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.



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