Because FDA's BIMO inspections can occur at any time during the clinical trial, it is imperative for medical device sponsors to be prepared from the very beginning.
The agency's BIMO division has outlined four ongoing global issues for the medical device industry to focus on (based on CDRH Compliance Actions and Inspectional Data, 2006):
Listed in Table 1 (above) are some of the most prevalent reported sponsor deficiencies over an eight-year period of FDA BIMO inspections.
For more than a year, we have pursued the BIMO
order with our EPS partners, funding large development costs and enduring numerous engineering changes and challenges as well as the usual delays expected when doing business with government entities.
Summary 8 BIMO (Biscuiterie Industrielle Du Moghreb): Operational Indicators
Summary 9 BIMO (Biscuiterie Industrielle Du Moghreb): Competitive Position 2006
Interview with FDA CBER (Biologics) BIMO Branch Chief Patricia Holobaugh
An interview with FDA's CDER BIMO Director Joanne Rhoads
Successfully completing BIMO
and QSR inspections is a very significant achievement for DexCom as we progress toward being a commercial enterprise capable of launching a product, especially as the inspections occurred earlier than we would have expected, only four months after filing our first-ever PMA.
All of these new iMEMS gyroscopes leverage ADI's industry-leading iMEMS monolithic gyroscope technology and patented high-volume BiMOS process with years of proven field reliability.
The UOC III is manufactured using the latest diffusion processes available, combining BiMOS 2001 (a process which is unique to Philips) with CMOS18 Flash.
Today NJR is a major manufacturer of silicon ICs, including bipolar, MOS, and BIMOS IC's; of GaAs IC's; and of microwave products.