Chicago, IL, March 06, 2016 --(PR.com
)-- This workshop will help the device manufacturer through a unique format of explanations, discussions and practical applications. The course is built on modules based on the Global Harmonization Task Force (GHTF) guidance document on the control of products and services obtained from suppliers.
During this 2 day workshop, Atlas Systems speaker Dan O'Leary will speak about the regulatory requirements in the Quality System Regulation (QSR), ISO 13485:2003, the Medical Device Directive (MDD), EN ISO 13485:2012 and other requirements.
The workshop will also cover:
-Determining when a supplier is a contract manufacturer
-Deciding on a required QMS for a company that makes only components
-When to rely on the supplier’s third party QMS certificate
-When to conduct second party audits and establishing their scope
-Preparing suppliers for unannounced visits based on the MDD and EU expectations
-Creating requirements for UDI when the supplier is involved in the device label
-The role of medical device risk management ISO 14971:2007 for component suppliers
Registration Link: http://bit.ly/1KuskVX