| | A number of different companies may be involved in the conception, design, manufacturing, marketing and distribution of health technologies. These include specification developers, designers, parts and subassembly suppliers, contract manufacturers, manufacturers, and initial distributors of imported products. 
Because of the vast experience of its talented consultants, BSI is uniquely positioned to assist these different stakeholders on one or more subjects below, no matter where you currently are situated on the technology life cycle shown above.  | Design | development of clinical specifications | | assessment of safety and efficacy | | risk analysis in compliance to Design Control of QS regulation | | risk management per ISO 14971 standard | | sourcing of parts and subassemblies |
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| Manufacturing | outsourcing alternatives | | supplier qualification | | sourcing of parts and subassemblies | | quality system management | establishment of policies and procedures | | ISO 9001:2000 registration and audits | | ISO 13845:2003 registration and audits |
| | regulatory compliance | FDA registration | | listing of products with the FDA | | PMA and 510k applications | | compliance to FDA QS regulation | | recall program | | device tracking program | | complaints management and reporting | | response to 483 reports and warning letters |
| | risk management per ISO 14971 standard | | Investigation of patient/user incidents, failure analysis, litigation defense |
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| Initial Distribution (of imported products) | registration with the FDA | | recall program | | device tracking program | | complaints management | | acting as “foreign agent” for foreign companies | | Investigation of patient/user incidents, failure analysis, litigation defense |
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IMPORTANT NOTES: | Confidentiality. BSI will sign a confidentiality agreement with the client before starting any consulting work that involves the use of confidential information. This agreement will protect the client information against unauthorized disclosure (except as required by law). | | Conflict of Interest. In order to preserve its clients' interests and confidential information, BSI will sometimes decline to accept certain assignments in order to avoid conflict of interest, protect its own integrity and impartiality. We hope you understand our stringent policy and accept our apologies in advance. |
Contact Information- Electronic mail info@BSI-Consulting.com
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