Seminar on Managing Suppliers in the Medical Device Industry in Boston

Event Date: October 22nd – 23rd 2015
Speaker : Dan O’Leary
Duration: 2 days
Seminar Link:

Online PR News – 02-September-2015 – Boston, MA – Atlas Systems is going to organize a seminar on "Managing Suppliers in the Medical Device Industry" on October 22nd - 23rd 2015.

This seminar would help the device manufacturer through a unique format of explanation, discussion, and practical application. The course is built of modules based on the Global Harmonization Task Force (GHTF) guidance document on the control of products and services obtained from suppliers.

During this 2 days of seminar Our 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 seminar would also cover in details:

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 :
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