Lecture 9_Assurance_Cases

Lecture 9_Assurance_Cases - U. S. Department of Health and...

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Center for Devices and Radiological Health U. S. Department of Health and Human Services Assurance Cases Richard Chapman FDA Drexel University May 25, 2011
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Center for Devices and Radiological Health Regulatory Challenges
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Center for Devices and Radiological Health Let’s compare and contrast… Regional variation in Standards use in the medical arena Either consensus standards provide a presumption of conformity EU and others Or they provide a pathway to easier conformity assessment US Either way the standard itself does not provide assurance ….compliance with it can
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Center for Devices and Radiological Health The standard must codify attributes which can be objectively assessed in a product by a third party Regulators need to regulate products so the attributes of the standard must be evident in the product or its design documentation This excludes many process standards from being useful to regulators!
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Center for Devices and Radiological Health ‘Software’ standards IEC 62304 Requirements for lifecycle processes in software development But no requirements for the software itself These processes are not quality processes They are in addition to them! They are moderated by the quality processes How do you determine compliance unless you are a developer? Needs deep knowledge of the culture! Hard for a corporate culture to assure itself of compliance!
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Center for Devices and Radiological Health IEC 60601-1 3 rd edition Clause 14 has software requirements which relate to the product but which are a little difficult to assess Clause 14.4 refers to development lifecycle and mentions IEC 62304 a) COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS; b) fail-safe functions; c) redundancy; d) diversity; e) partitioning of functionality; f) defensive design, e.g., limits on potentially hazardous effects by restricting the available output power or by introducing means to limit the travel of actuators. The architecture specification shall take into consideration: g) allocation of RISK CONTROL measures to subsystems and components of the PEMS; NOTE—Subsystems and components include sensors, actuators, PESS, and interfaces. h) failure modes of components and their effects; i) common cause failures; j) systematic failures; k) test interval duration and diagnostic coverage; l) maintainability; m) protection from reasonably foreseeable misuse; n) the NETWORK/DATA COUPLING specification, if applicable. Requires mandatory compliance with ISO 14971 standard for risk management processes
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Center for Devices and Radiological Health Ah Hah! So here we have some concrete examples of implementation
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This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

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Lecture 9_Assurance_Cases - U. S. Department of Health and...

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