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James Daniel
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James Daniel
FDA Cybersecurity Premarket 2024: SBOM-Driven Compliance Under Section 524B
FDA's final Cybersecurity Premarket Guidance (27 September 2023) and the new Section 524B of the FD&C Act have rewritten device-maker obligations. Starting 1 October 2023,
July 10, 2025
James Daniel
QMSR Final Rule 2024
A Startup's End-to-End Roadmap for Seamless ISO 13485 Alignment Before 2 February 2026 (≈5 100 words — feel free to trim or break into a series) Table
July 10, 2025
James Daniel
Risk-Based Validation 2.0
Mastering FDA's Computer Software Assurance Framework Before It Goes Final By Vital Compliance | Updated 16 June 2025 Executive Snapshot What changed? FDA's CSA Draft Guidance (Sept 2022) replaces
July 10, 2025
James Daniel
eSTAR & De Novo 2025
Navigating the Mandatory Electronic Submission Era Without Losing Time — or Cash Prepared by Vital Compliance | Updated 17 June 2025 Executive Snapshot Beginning 1 October 2025, every
July 10, 2025
James Daniel
AI/ML Medical Devices 2025
Crafting a Predetermined Change Control Plan (PCCP) for Rapid — but Safe — FDA Clearance Prepared by Vital Compliance | Updated 17 June 2025 Executive Snapshot FDA's April
July 10, 2025
James Daniel
Q‑Submission Strategy 2025
Pre‑Submission Tactics That Slash Review Time, Cost, and Stress Prepared by Vital Compliance | Updated 17 June 2025 Executive Snapshot FDA's 2023 update to the Q‑Submission Guidance formalised
July 10, 2025
James Daniel
Post‑Market Cybersecurity 2025
Patch Management & Section 524B Compliance without Blowing Your Budget Prepared by Vital Compliance | Updated 17 June 2025 Executive Snapshot Since 1 October 2023, every cleared software‑enabled
July 10, 2025
James Daniel
Fractional QA/RA 2.0
Scaling Compliance in a Remote‑First World — Without Ballooning HeadcountPrepared by Vital Compliance | Updated 17 June 2025 Executive Snapshot The 2024 QMSR rule, 2025 cybersecurity mandates,
July 10, 2025
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