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The International Conference on Medical Device Standards and Regulations will bring together regulators and standards leaders from around the world to report on some of the latest developments in this arena and discuss how medical manufacturers can prepare to ensure continued global market access and regulatory compliance. For more information:  http://www.aami.org/events/Content.aspx?ItemNumber=3071&navItemNumber=2929

On January 10, 2018, the FDA will hold a webinar for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required. For more details: https://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm587582.htm

To all of our friends, clients, and associates being impacted by the wind, rain, storm surge, and flooding from Hurricane Irma, please know we are thinking of you and praying for your safety. Whether you are evacuating or hunkering down to wait it out, stay safe and stay strong, #FloridaStrong, #Irma2017. http://www.nhc.noaa.gov/

Focus’ CVS Mark Walker (also a member of AAMI’s faculty) will be an instructor at the Quality System Requirements & Industry Practice Course, Austin, TX, June 9-12, 2017.  The 4-day comprehensive course provides the basic knowledge and skills needed to develop a quality system program that conforms with FDA’s Quality System regulation.  For more info:  [...]

Focus’ CVS Mark Walker (also a member of AAMI’s faculty) will be an instructor at the Quality System Requirements & Industry Practice Course, Arlington, VA, April 18-21, 2017.  The 4-day comprehensive course provides the basic knowledge and skills needed to develop a quality system program that conforms with FDA’s Quality System regulation.  For more info:  [...]

The website has been updated with a new look and feel with a much more mobile friendly format.  We hope you find the new format pleasing and the information valuable.