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

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.

What areas will the new standard address? What will be the impact on product engineering and software development processes?   How can audit preparation go from weeks to hours? This session will provide the answers to these and many more questions.

Agenda Highlights:

  •             Overview of Ruling: What is the ruling?  What you need to know?  What does it mean to you?
  •             What are the challenges for an orginazation that is classified as MDDS and has to meet Class 1 requirements?
  •             What are the benefits to the company beyond conformance to the ruling?
  •             Solution Demo
  •             How our customers are coping with it, using Integrity
  •             Q & A


What you will learn:

  •             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;

                   -     See how Integrity can be integrated into existing processes and tools.

Who should attend?

  •             Those responsible for Product Delivery: C level executives like CIO or CEO
  •             Those responsible for Compliance: Senior level Regulatory, Compliance, Legal  Personnel
  •             Those responsible for the Development Lifecycle: VP of Engineering, Senior level Quality Assurance

    To register for this online event, please click here.

    Timezone: EDT
    Apr 19, 2012 01:00 PM
    Presented by : Anusha Subramaniam, Customer Solutions Engineer, PTC
    Michael Gross, Customer Solutions Engineers, PTC
    Steve Mostello, Customer Solutions Engineer, PTC, joins us for the Q&A Session
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