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MedDeviceAudit.com

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𝐓𝐡𝐞 "𝐀𝐮𝐝𝐢𝐭𝐨𝐫-𝐢𝐧-𝐚-𝐁𝐨𝐱" 𝐟𝐨𝐫 𝐌𝐞𝐝𝐓𝐞𝐜𝐡 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 & 𝐐𝐌𝐒𝐑 𝟐𝟎𝟐𝟔 𝐑𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬.

𝐎𝐯𝐞𝐫𝐯𝐢𝐞𝐰:
MedDeviceAudit.com is a specialized, AI-driven platform designed to automate the gap analysis and remediation of medical device technical files. Built specifically for the transition to the new FDA Quality Management System Regulation (QMSR) and ISO 13485:2016, our platform serves as a force multiplier for Quality Assurance (QA) and Regulatory Affairs (RA) teams.

While the FDA transitions to AI-powered inspection tools like Elsa 4.0 and the HALO data platform, MedDeviceAudit provides manufacturers with an equivalent technological edge—ensuring technical documentation is "audit-ready" before it ever reaches a regulator's desk.

𝐊𝐞𝐲 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐬 & 𝐂𝐚𝐩𝐚𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬:

The 9P/2G Evidence Engine: Our proprietary logic performs deep-tier analysis of technical requirements, identifying gaps in Design Requirements Specifications (DRS), Management Reviews, and Design History Files (DHF).

Surgical Remediation Roadmaps: Beyond simple gap detection, we generate expert, 7-step remediation plans that provide clear, actionable paths to compliance, moving teams from "identification" to "controlled response" in under 120 seconds.

Stateless Ephemeral Processing: Engineered for maximum Intellectual Property (IP) protection, our platform utilizes a stateless architecture. All uploaded technical files are processed in volatile memory (RAM) and purged immediately upon report generation.

Zero-Training Data Privacy: We maintain a strict Non-Retention policy. Customer data is never stored on persistent databases and is never utilized for AI model training or fine-tuning.

QMSR 2026 Transition Tools: Specific modules designed to audit legacy 21 CFR 820 documentation against the new 2026 FDA inspection standards and the loss of the §820.180(c) safe harbor.

𝐖𝐡𝐨 𝐖𝐞 𝐒𝐞𝐫𝐯𝐞:
We empower mid-market medical device manufacturers and startups to bypass the slow, error-prone manual audit process. By automating the "red-teaming" of technical files, we help organizations reduce the risk of FDA 483 observations, minimize product liability exposure, and accelerate time-to-market.

Company Details

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Categories

Computing Solutions – Hardware and Software > Compliance and Regulatory Software
Med Device Med Rect 4.30.26
MedDevice_3:1_8.1.20
Med Device