Reclassification of MDDS as Class 1 Devices: Implementing a Compliant Quality Management System

Hosted by PTC

Presenters: Michael Gross, Customer Solutions Engineer, PTC &
Anusha Subramaniam, Customer Solutions Engineer, PTC

In 2011, the FDA published a final rule reclassifying Medical Device Data Systems (MDDS) as Class 1 medical devices exempt from 510(k) premarket notification requirements.

In this On-demand you will learn about:

• Background for the requirements of the MDDS ruling

• Benefits to being compliant

• Integrity Medical Device Solution – An overview:

    -   Out of the box” artifacts to support FDA Class 1 requirements;

    -   Improve productivity & quality, streamline compliance and gain complete product visibility;

    -   Eliminate time consuming manual processes which can be error prone through traceability;

    -   Unite stakeholders onto a common platform to provide automation & common processes;

• How Integrity can be integrated into existing processes and tools.

Original broadcast date: April 19, 2012

Time: 1:00 PM EST

Duration: 35 minutes