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£59.43
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£59 today · cheaper than every other day in the last 3 months
Modern Medical Device Regulation: Volume 3: Operational Governance
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Most common price: £59 (58 days, 100.0%)
Price range: £59 - £59
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Description
Modern Medical Device Regulation, Volume 3: Operational Governance advances the regulatory discussion from reliability, classification, and premarket pathway strategy into the operational architecture that sustains safety across the total product lifecycle. This expanded hardcover edition includes additional material, refined structural integration, and enhanced discussion of how operational risk is governed after market entry through interconnected quality systems, cross-domain controls, and lifecycle feedback mechanisms. Rather than treating compliance as a collection of discrete regulatory obligations, this volume presents risk as a system-level property emerging across design, manufacturing, software, cybersecurity, reprocessing, and post-market surveillance functions. Key topics include: Risk as a system-level architectural property Integration across ISO 13485 and ISO 14971 quality boundaries Production and supply chain risk interfaces IEC 62304 software lifecycle governance Cybersecurity as a safety-critical quality obligation Reprocessing and sterility as lifecycle risk domains Residual risk and benefit-risk decision architecture Audit-ready traceability across regulatory jurisdictions Drawing on U.S., E.U., Japanese regulatory frameworks, this expanded edition demonstrates how lifecycle governance is operationalized through structured feedback loops, controlled change processes, and centralized risk-benefit oversight. Designed for regulatory professionals, quality leaders, clinical engineers, and college-level programs, Volume 3 provides a systems-level framework for sustaining defensible medical device governance in software-intensive and globally regulated environments.
Product Specifications
- Format
- hardcover
- ASIN
- B0GWVKPJXK
- Domain
- Amazon UK
- Release Date
- 11 April 2026
- Listed Since
- 11 April 2026
Barcode
No barcode data available
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