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

Regulatory Compliance & The Regulatory Compliance & The Role of Biomedical OutsourcingRole of Biomedical Outsourcing

Michael CarpenitoMichael Carpenito

Scott PletzerScott Pletzer

MEDICAL DEVICE OUTSOURCING SOLUTIONS

2006 CARZER Technologies, LLC All Rights Reserved

Who is CARZER?Who is CARZER?

CARZER Technologies has over 20 CARZER Technologies has over 20 years experience in the medical device years experience in the medical device industry. We provide solutions to industry. We provide solutions to organizations regulated by ISO organizations regulated by ISO standards and/or FDA regulations.standards and/or FDA regulations.


CARZER’s ServicesCARZER’s Services

• Quality management systems Quality management systems • Compliance Compliance • Training & development Training & development • Contract engineering & Contract engineering &

manufacturingmanufacturing• Regulatory preparation & Regulatory preparation &

submissionsubmission• Supply base managementSupply base management


Outsourcing Reaches the Outsourcing Reaches the Entire Biomedical IndustryEntire Biomedical Industry

• AcademiaAcademia• EntrepreneursEntrepreneurs• Biomedical organizationsBiomedical organizations• Funding organizationsFunding organizations• Legal counselLegal counsel


Factors Driving OutsourcingFactors Driving Outsourcing

• Cost effectivenessCost effectiveness• ResourcesResources• Speed to marketSpeed to market• ExpertiseExpertise• Competitive edgeCompetitive edge


Today’s OutsourcingToday’s Outsourcing

……It’s about systems and infrastructure, It’s about systems and infrastructure, training and awareness, design houses training and awareness, design houses for prototyping, contract manufacturing, for prototyping, contract manufacturing, third party testing and clinical services, third party testing and clinical services, regulatory representation, experienced regulatory representation, experienced and skilled personnel, without permanent and skilled personnel, without permanent salaries. It’s more than consulting as we salaries. It’s more than consulting as we know it…know it…


Outsourcing RelationshipsOutsourcing Relationships

PreferredOutsource

EstablishedPartnership

StrategicAlliance

InitialContact


Achieving Outsourcing Achieving Outsourcing SuccessSuccess

• Begin earlyBegin early• Due diligenceDue diligence• Common objectivesCommon objectives• CommunicateCommunicate• Trust and respectTrust and respect


Regulatory ComplianceRegulatory ComplianceFDA & ISOFDA & ISO


Infrastructure to Ensure Infrastructure to Ensure Regulatory ComplianceRegulatory Compliance

• Quality management systemQuality management system• Training & awarenessTraining & awareness• Management commitmentManagement commitment


Balancing Technology & Balancing Technology & InfrastructureInfrastructure

• Technology drives an Technology drives an organization, but infrastructure organization, but infrastructure keeps it running smoothlykeeps it running smoothly

• Focus on the technology with the Focus on the technology with the right balance of infrastructure, or right balance of infrastructure, or the technology will erodethe technology will erode

• Strategic infrastructure is key, Strategic infrastructure is key, too much becomes ineffectivetoo much becomes ineffective


The Cost of ComplianceThe Cost of Compliance

• Compliance has Compliance has a pricea price

• Non-compliance Non-compliance has a much has a much greater pricegreater price


QuestionsQuestions

MEDICAL DEVICE OUTSOURCING SOLUTIONS

Documents

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