| | 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. | Technology assessment | safety, efficacy and effectiveness | | potential risks and liabilities exposures | | after-sales support required | | technical expertise required |
| | Distribution (wholesale, retail and/or rental) | FDA general controls against misbranding and adulteration | | state drug and device distributor licensing | | recall program | | device tracking program | | complaints management | | sourcing of alternative parts and subassemblies | | service options (internal, OEM, third parties) | | compliance to customer quality demands | | remarketing (used technologies) |
| | Safety and liability | safety (quality) program | | patient/user incident investigation | | liability insurance | | litigation defense |
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Contact Information- Electronic mail info@BSI-Consulting.com
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