Partnering with Suppliers to Create a Robust Regulatory Compliance System

Event Time

Originally Aired - Wednesday, August 11 10:20 AM - 10:50 AM

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Event Location

Location: Center Stage (Lobby)


Event Information

Title: Partnering with Suppliers to Create a Robust Regulatory Compliance System

Event Type: Center Stage Session

Cost: Free Education


Description

The regulatory and quality requirements vary depending on the type of product being manufactured and by who is doing the manufacturing. While it is inherent that the OEM or Finished Medical Device manufacturer has set regulatory requirements, many are not aware that suppliers must also comply to regulatory requirements based on the type of product or service being performed. This session will address: 

  • Distinction between the types of products being manufactured and the respective quality and regulatory requirements associated with them 
  • Questions to ask potential or existing suppliers in order to ensure regulatory compliance for their finished products 
  • Obligations required of suppliers versus obligations required of the OEM  
  • Regulatory requirements for both upstream (the OEM) and downstream (suppliers) manufacturers and how they help create a smoother and more robust regulatory compliance system for all 
  • Case Studies to be examined during this presentation include three types of products and how the regulatory bodies determine the categories (Component, Subcontracted Finished Device, Medical Device) and what that means for the OEM and the supplier

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