1. Regulatory Compliance & The Role of Biomedical Outsourcing Michael Carpenito Scott Pletzer MEDICAL DEVICE OUTSOURCING SOLUTIONS

2. 2006 CARZER Technologies, LLC All Rights Reserved Who is CARZER? CARZER Technologies has over 20 years experience in the medical device industry. We provide solutions to organizations regulated by ISO standards and/or FDA regulations.

3. 2006 CARZER Technologies, LLC All Rights Reserved CARZER’s Services Quality management systemsQuality management systems ComplianceCompliance Training & developmentTraining & development Contract engineering & manufacturingContract engineering & manufacturing Regulatory preparation & submissionRegulatory preparation & submission Supply base managementSupply base management

4. 2006 CARZER Technologies, LLC All Rights Reserved Outsourcing Reaches the Entire Biomedical Industry AcademiaAcademia EntrepreneursEntrepreneurs Biomedical organizationsBiomedical organizations Funding organizationsFunding organizations Legal counselLegal counsel

5. 2006 CARZER Technologies, LLC All Rights Reserved Factors Driving Outsourcing Cost effectivenessCost effectiveness ResourcesResources Speed to marketSpeed to market ExpertiseExpertise Competitive edgeCompetitive edge

6. 2006 CARZER Technologies, LLC All Rights Reserved Today’s Outsourcing …It’s about systems and infrastructure, training and awareness, design houses for prototyping, contract manufacturing, third party testing and clinical services, regulatory representation, experienced and skilled personnel, without permanent salaries. It’s more than consulting as we know it…

7. 2006 CARZER Technologies, LLC All Rights Reserved Outsourcing Relationships Preferred Outsource Established Partnership Strategic Alliance Initial Contact

8. 2006 CARZER Technologies, LLC All Rights Reserved Achieving Outsourcing Success Begin earlyBegin early Due diligenceDue diligence Common objectivesCommon objectives CommunicateCommunicate Trust and respectTrust and respect

9. 2006 CARZER Technologies, LLC All Rights Reserved Regulatory Compliance FDA & ISO

10. 2006 CARZER Technologies, LLC All Rights Reserved Infrastructure to Ensure Regulatory Compliance Quality management systemQuality management system Training & awarenessTraining & awareness Management commitmentManagement commitment

11. 2006 CARZER Technologies, LLC All Rights Reserved Balancing Technology & Infrastructure Technology drives an organization, but infrastructure keeps it running smoothlyTechnology drives an organization, but infrastructure keeps it running smoothly Focus on the technology with the right balance of infrastructure, or the technology will erodeFocus on the technology with the right balance of infrastructure, or the technology will erode Strategic infrastructure is key, too much becomes ineffectiveStrategic infrastructure is key, too much becomes ineffective

12. 2006 CARZER Technologies, LLC All Rights Reserved The Cost of Compliance Compliance has a priceCompliance has a price Non-compliance has a much greater priceNon-compliance has a much greater price

13. 2006 CARZER Technologies, LLC All Rights Reserved Questions MEDICAL DEVICE OUTSOURCING SOLUTIONS