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The combination of increasing regulatory controls, high risks involved, and a very litigious environment require distribution companies to organize itself appropriately, develop rigorous policies and procedures, verify the implementation of these policies and procedures, train their staff, and prepare itself for inevitable liability exposures.

Because of the vast experience of its talented consultants, BSI is uniquely positioned to assist distributors in one or more subjects below.

bulletTechnology assessment
bulletsafety, efficacy and effectiveness
bulletpotential risks and liabilities exposures
bulletafter-sales support required
bullettechnical expertise required
bulletDistribution (wholesale, retail and/or rental)
bulletFDA general controls against misbranding and adulteration
bulletstate drug and device distributor licensing
bulletrecall program
bulletdevice tracking program
bulletcomplaints management
bulletsourcing of alternative parts and subassemblies
bulletservice options (internal, OEM, third parties)
bulletcompliance to customer quality demands
bulletremarketing (used technologies)
bulletSafety and liability
bulletsafety (quality) program
bulletpatient/user incident investigation
bulletliability insurance
bulletlitigation defense

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Contact Information

Electronic mail info@BSI-Consulting.com

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