ASQ Biomedical NCDG Roundtable (May) : Sterilization of Health Care Products by Radiation (ANSI/AAMI/ISO 11137 -1 & -2: 2006

May 31, 2012 – Triple Ring Technologies, Newark

Sterilization of medical devices using any sterilization method is perhaps one of the highest risk and least understood process steps in the development and manufacture of medical devices. For many industrial medical devices, sterilization either by E-Beam or Gamma radiation is the preferred See more…

ASQ Biomedical NCDG Roundtable (June): Cleanroom Validation

June 28, 2012 – Triple Ring Technologies, Newark

Roundtable details pending. Early Registration is open at Acteva Link provided. See more…

One and Half-day In-person Seminar: Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop

June 28-30, 2012 – Grand Hyatt San Francisco, San Francisco

Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary investment burn. Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at FDA nearly twice a month negotiating 510(k)/IDE/PMA issues for his clients. He will See more…

ASQ Biomedical NCDG Roundtable (July): Creating a quality system from scratch

July 26, 2012 – Triple Ring Technologies, Newark

Roundtable details pending. Early Registration is open at Acteva Link provided. See more…

2-day In-person Seminar: CAPA Systems for Medical Device Manufacturers

August 16-18, 2012 – Grand Hyatt San Francisco, San Francisco

Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in its published information on Warning Letters. FDA cited the CAPA subsystem in 81 of 89, 91%, of Warning Letters issued in 2010, the most recently available data. The See more…

ASQ Biomedical NCDG Roundtable (August): How a Quality Engineer Adds Value to an Organization

August 29, 2012 – Triple Ring Technologies, Newark

Roundtable details pending. Early Registration is open at Acteva Link provided. See more…

BIOMEDevice San Jose 2012

December 4-6, 2012 – San Jose Convention Center, San Jose

BIOMEDevice San Jose provides in-depth education, qualified suppliers, and leading-edge products and services required to develop your next-generation medical devices. It gathers medtech professionals and leading medical OEM suppliers together to provide you with immediate hands-on access to the See more…