LONDON, ENGLAND / ACCESSWIRE / May 21, 2015 / Bio-AMD, Inc. and Bio Alternative Medical Devices Ltd., our majority owned medical devices subsidiary (together "Bio-AMD," "We" or the "Company" OTCQB: ...

The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is ...

Today, Amcor, a global leader in developing and producing responsible packaging solutions, announced that its Winterbourne site, a center of excellence for medical and healthcare packaging, has ...

Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR ...

Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

The U.S. FDA’s proposal to restructure the Quality System Regulation (QSR) with ISO 13485, the international quality system standard, is a major shift for affected industry, but there are strictly ...