Wednesday, February 02, 2011 8:24 AM
MedicalDeviceSummit Supplier Controls Conference: Diversity and Complexity are Unique Challenges
By Thomas Maeder
Supplier control issues will remain high on the list of FDA’s Center for Devices and Radiological Health and Office of Regulatory Affairs targets for inspection and enforcement activity this year. Unique issues in medical device supplier management include the diversity of supplied products and services, the varying complexity of materials and components, and the wide range of risk from different products – even from different products provided by the same supplier to the same customer. MedicalDeviceSummit’s conference on this topic highlighted some key issues.
Supply chain management is problematic in any industry – just consider the Boeing 787 Dreamliner – but challenges are particularly acute in the medical device field, where manufacturers rely on countless component and service providers, many of who may lack familiarity with the stringent demands of a highly regulated sector. “I think we have more suppliers than employees,” bemoaned one industry speaker at the MedicalDeviceSummit conference on Supplier Controls and Quality Managemen more...
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