Standards guides.
Every guide we've published on Standards.
25 guides tagged Standards
AAMI TIR57 vs TIR97: Medical Device Risk Management Guide
Compare AAMI TIR57 vs TIR97. Learn how these cybersecurity risk management standards differ and how to apply them for FDA premarket and postmarket compliance.
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Board-Ready Cybersecurity 1-Pager + Pre-Read
Board-Ready 1-Pager + Pre-Read Pack When the board asks 'are we covered on cyber?', this is the answer in one page.
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Budget-Aware Engagement Structures
250+ 0 6–10 wk FDA submissions supported Cybersecurity rejections Class II eSTAR cyber pack SINCE 2014 TRACK RECORD TYPICAL TIMELINE
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Cloud-Only MedTech Threat Surface Map
250+ 0 6–10 wk FDA submissions supported Cybersecurity rejections Class II eSTAR cyber pack SINCE 2014 TRACK RECORD TYPICAL TIMELINE
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Cost-of-Delay vs. Cost-of-Cyber Comparison
250+ 0 6–10 wk FDA submissions supported Cybersecurity rejections Class II eSTAR cyber pack SINCE 2014 TRACK RECORD TYPICAL TIMELINE
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CPE vs PURL for Medical Device SBOMs: Which Identifier and When
How CPE and PURL identifiers differ, why medical device SBOMs need both, and how to map PURL to CPE for FDA postmarket CVE monitoring under Section 524B.
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Cyber Insurance Limits Guide for MedTech
Insurance Limits: Standard vs. Enterprise Match Cyber, E&O, and product-liability limits we carry, and how they typically compare to enterprise procurement asks.
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Cybersecurity in a QMS-in-Flux Environment
Cybersecurity When Your QMS Is in Flux How to keep cyber moving while you migrate from 21 CFR 820 to QMSR or build a QMS for the first time.
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CycloneDX vs SPDX: Medical Device SBOM Compliance Guide
Does the FDA prefer CycloneDX or SPDX? Compare SBOM formats for medical device cybersecurity compliance and premarket 510(k) submissions.
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