Unannounced Audit Best Practices and Notified Body Communications

Unannounced Audit Best Practices and Notified Body Communications

Unannounced Audit Best Practices and Notified Body Communications 1 Hour Video | Sarah H. Stec, Esq., RAC, LNE/G-MED North America, Inc. Under the EU Commission Recommendation 2013/473/EU, unannounced audits must become an established practice for medical device...
Integration of Quality Management Systems Across the Organization

Integration of Quality Management Systems Across the Organization

Integration of Quality Management Systems Across the Organization 1 Hour and 5 Minute Video | Jodie Bastian, Stryker As innovation in new technologies continues to produce an ever expanding medical device industry, one particular area of concern is the integration of...
New Contractual Arrangements with Notified Bodies and Suppliers

New Contractual Arrangements with Notified Bodies and Suppliers

New Contractual Arrangements with Notified Bodies and Suppliers 1 Hour and 15 Minute Video | Elisabethann Wright, Hogan Lovells  The September 2013 recommendations require contractual authorization for notified bodies to make unannounced audits, and to perform product...