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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.

bulletDesign
bulletdevelopment of clinical specifications
bulletassessment of safety and efficacy
bulletrisk analysis in compliance to Design Control of QS regulation
bulletrisk management per ISO 14971 standard
bulletsourcing of parts and subassemblies
bulletManufacturing
bulletoutsourcing alternatives
bulletsupplier qualification
bulletsourcing of parts and subassemblies
bulletquality system management
bulletestablishment of policies and procedures
bulletISO 9001:2000 registration and audits
bulletISO 13845:2003 registration and audits
bulletregulatory compliance
bulletFDA registration
bulletlisting of products with the FDA
bulletPMA and 510k applications
bulletcompliance to FDA QS regulation
bulletrecall program
bulletdevice tracking program
bulletcomplaints management and reporting
bulletresponse to 483 reports and warning letters
bulletrisk management per ISO 14971 standard
bulletInvestigation of patient/user incidents, failure analysis, litigation defense
bulletInitial Distribution (of imported products)
bulletregistration with the FDA
bulletrecall program
bulletdevice tracking program
bulletcomplaints management
bulletacting as “foreign agent” for foreign companies
bulletInvestigation of patient/user incidents, failure analysis, litigation defense

IMPORTANT NOTES:

bulletConfidentialityBSI 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).
bulletConflict 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.

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Contact Information

Electronic mail info@BSI-Consulting.com

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