Lecture 10 Standards and Biocompatibility 6.1.11

Lecture 10 Standards and Biocompatibility 6.1.11 - 1...

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1 Introduction § Who are we? § Ryan Siskey, M.S. § Biomedical Engineering § Angelina Duggan, Ph.D. § Chemistry and Human Health Risk Assessment § What are we going to discuss? § Role of Standards in Preclinical Testing § Biocompatibility and Risk Assessment § How does it fit?
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2 Medical Device Product Feasibility Verify Design Transfer Launch Post Market Surveillance NDA Composition Human factors in Product Design & Function Use comparison w/ competitive products Vendor ID, Qualification/Selection QMS Gap Analysis Functional Performance of Critical to Customer Reqs. Materials Selection Packaging/Labeling Requirements Implement Design Control Stage Gate Stage Gate Stage Gate Stage Gate Tech Assessment IP Assessment Regulatory Strategy Reliability Engineering Manufacturing Process Troubleshooting Process Control/Quality Assurance Product Specification Development Plan Preclinical Testing Strategy Regulatory Compliance Process Verification, Validation, and Statistical Process Support Corrective and Preventive Actions (CAPAs) Medical Device Reporting (MDR) Safety/Performance Assessments Retrieval Analysis Registry/Clinical Database
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3 Click to edit Master subtitle style The Role of Standards in Preclinical Testing Ryan Siskey, M.S. Senior Manager Biomedical Engineering Practice
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4 “A standard is a common language that promotes the flow of goods between buyer and seller and protects the general welfare.” ASTM Examples: n   n n  Environment Site Assessment n  Jet Fuel ABOUT STANDARDS What is a standard
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5 § AID in design, manufacturing, performance, operation and maintenance § ADVANCE safety, health, quality § INCREASE public interest, product certainty, and information availability § TRANSFER technology to the marketplace via standards, handbooks, manuals, and training ABOUT STANDARDS Why they are important
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6 § Developed voluntarily and used voluntarily § Cited in a contract – § Means of communication and quality assurance § Government agencies reference them in codes, certification, regulations, and laws (US: P.L. 104-113) § Over 3,400 ASTM International standards are used as the basis for national standards by reference in regulation in over 75 countries § Used by thousands of individuals/companies/agencies globally to ABOUT STANDARDS How they are used
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Who develops standards? § Governments (regulatory) and the private sector (consensus and industry) both develop standards ••••• IEC,ISO, etc. US(ANSI)
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Lecture 10 Standards and Biocompatibility 6.1.11 - 1...

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