Handbook of Medical Device Design

Forside
CRC Press, 14. sep. 2000 - 794 sider
The Handbook of Medical Device Design  provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include

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Andre utgaver - Vis alle

Handbook of Medical Device Design
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Vanlige uttrykk og setninger

activities application appropriate approved areas assessment audit auditors CE marking CENELEC certification component configuration item conformity cycle declaration of conformity defined determine development process documentation effectiveness Electronic Engineering ensure environment equipment Essential Requirements established European evaluation example failure rate fault tree analysis Fries functional hardware hazard analysis Human Factors identify implementation important input inspection integration intended interface International ISO/IEC manual manufacturer mark matrix Medical Device Directive meet methods mitigation modules monitor MTBF Notified Body operation organization parameters patent performance potential premarket problems procedures Quality Assurance quality system regulation regulatory reliability Requirements Specification risk safety sample software development software requirements Software Requirements Specification standards systematic faults tasks technical techniques trade secret trademark translation unit verification and validation

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Bibliografisk informasjon

TittelHandbook of Medical Device Design
ForfatterRichard C. Fries
Utgaveillustrert
UtgiverCRC Press, 2000
ISBN0824703995, 9780824703998
Lengde794 sider
  
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