For RA & QA teams · medical device compliance
ComplianceBrief watches FDA MedWatch around the clock, hashes every alert with SHA-256 the instant it is retrieved, and builds the timestamped record your next management review will need.
Infusion Pump Software - Recall Notice
FDA MedWatch
Cardiac Monitor - Battery Failure Risk
FDA MedWatch
Digital Health Technologies - Draft Guidance
FDA MedWatch
Every entry archived, timestamped, and exportable for audit
FDA medical device warning letters rose 96% from FY2023 to FY2024, from 24 to 47.
Source: FDA.gov enforcement data, FY2023–FY2024
Post-market surveillance scrutiny is increasing. Management reviews need to show alerts were monitored as they happened, not reconstructed after the fact. QMSR Clause 5.6.2 requires documented inputs to management review. A timestamped audit trail is that evidence.
The difference
Time saved: 2.5 hours per week·130 hours per year per person
How it fits
ComplianceBrief feeds verified alert evidence into your existing eQMS workflow. It does not replace Greenlight Guru, MasterControl, or any other quality system. It fills the gap those systems leave open: continuous FDA monitoring with cryptographic proof of receipt.
What ComplianceBrief does
What it complements (your eQMS)
Built for regulated environments. Every record ComplianceBrief produces is designed to be referenced directly by your auditor, not summarised for them.
Pricing
Start building your audit trail today. No credit card required, no procurement process. Paid plans start after founding access closes. You will be notified in advance.
After founding access closes
Pricing is being finalised for small and mid-size medical device teams. Founding access teams will be the first to know, and will have the option to continue before any charge applies.
Questions about pricing? Email support@compliancebrief.health
How it works
Continuous polling captures every alert the moment it is published, with no manual checks required.
SHA-256 hashing and immutable storage create a tamper-evident record at the point of retrieval.
Email digests, a shared dashboard, and one-click export for management review inputs.
The problem
Problem #1
Most regulatory teams rely on disparate sources such as spreadsheets with links, manual web searches, email alerts, and agency/specialized website review. This process is generating a lot of distraction for the team members due to multiple and duplicate e-mail alerts and internal e-mails forwarded by colleagues.
How ComplianceBrief solves it
One dashboard
Replaces multiple email subscriptions and manual checks.
Team-wide visibility
Everyone sees the same information. No inbox silos.
Searchable archive
Every past alert retrievable with full source proof.
Report insufficient resources for all priorities
MTI Medical Device Regulatory Report 2024 (n=700)
Lack confidence in their current QMS
Greenlight Guru State of Medical Device Industry 2025 (n=536)
Problem #2
Regulatory professionals report spending 3 to 8 hours per week on alert collection, not analysis. Headcount stays flat while post-market surveillance requirements expand.
79% of regulatory professionals report insufficient resources to complete all priorities.
How ComplianceBrief solves it
Automated monitoring
Eliminates manual website checks and inbox triage.
3 to 5 hours back per week
Time returned from collection to analysis.
Focus on analysis
Your team reviews impact instead of chasing alerts.
Problem #3
The QMSR, in effect since February 2, 2026, incorporates ISO 13485:2016 into US federal law. Clause 5.6.2 requires management review inputs to address applicable new or revised regulatory requirements.
Typical gaps a QMS auditor looks for
How ComplianceBrief supports your QMS
ComplianceBrief supports compliance workflows. It does not guarantee FDA compliance or replace your Quality Management System.
Product
Live today, plus what's on the roadmap.
The dashboard
Live features: real-time alerts, SHA-256 archive, compliance export. AI summarization and advanced search are in development.
Scope
ComplianceBrief is focused FDA MedWatch infrastructure. It is not an eQMS replacement.
What ComplianceBrief does
Cryptographic verification and audit-ready documentation. Replaces manual checking, email forwarding, and spreadsheet tracking.
What it complements
Greenlight Guru, MasterControl, and similar tools handle CAPAs, design controls, and document management. ComplianceBrief handles FDA alert monitoring. They work together.
FAQ
Security & compliance
SOC 2 Type II
Audit underway. Report available on request.
HIPAA-aligned
Architecture designed for PHI safeguards.
21 CFR Part 11
Supports electronic records documentation.
Encrypted
TLS in transit, AES-256 at rest.
Free for the first 100 teams. No credit card required, no procurement process. The timestamped, SHA-256 verified record your next management review will need.