These webinars will provide a working knowledge of Test Method Validation (TMV), also known as Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not important, the application of this very valuable statistical methodology is essential for a quality system. For more information: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5749
This 3-day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA's expectations and provides conceptual ways to meet compliance requirements. Relevant standards, FDA guidance documents, and other resources will be discussed that assist in determining compliance practices. For more [...]
As a medical technology developer who seeks to apply human factors engineering (HFE) effectively to produce safe and effective devices and to satisfy regulators' requirements and expectations, you may be frustrated that pre-existing guidance only describes how to perform specific HFE techniques but does not provide sample work products (e.g., test plans, test reports). A [...]
This comprehensive 2.5 day course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the life cycle of the product, from design…to manufacturing…through post-production. For more information: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5626
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: [...]