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Raw Materials Risk Management 


FDA and other governing bodies controlling the standards of medical devices are reaching deeper into the supply chains that support OEMs. As a result, OEMs are now re-evaluating their supplier quality strategies to ensure that every machined component and piece of raw material entering their production floor is 100 percent validated – making quality management a more complex undertaking. Evaluating material suppliers from a risk mitigation standpoint has become a challenging, and somewhat elusive, undertaking for manufacturers of medical devices. The session will answer the questions: What is risk mitigation as it applies to raw material suppliers in the medical device industry? How can orthopaedic device companies combat it?

Session Takeaways:

  • Material Identity, Material Integrity & Process Validation
  • Supply Chain Management
  • Catastrophic Event Recovery
  • Material Quality and Consistency
  • Quality Systems and Control Processes
  • Employee Training

Who Should Attend:

  • Materials/Commodity Management
  • Product Management
  • Purchasing
  • Quality Control
  • Research/Development/Design
  • Supply Chain Management
  • Manufacturing
David Mersereau, Senior Vice President/General Manager, Boston Centerless
DaveMersereau webDavid Mersereau is the Senior Vice President/General Manager at Boston Centerless. Mr. Mersereau has over 38 years of experience in operations, manufacturing, quality systems and control processes, supply chain management, material testing and validation and lean manufacturing. Prior to working at Boston Centerless, Mr. Mersereau held senior level positions at Altron, Sanmina, North American Industries and George Roberts.