ComplianceBrief aggregates FDA MedWatch alerts into a shared dashboard, SHA-256 hashes each document at retrieval, and generates exportable records for management review. Your team gets coverage you can prove.
Recent Updates
3 new alerts today
Class I Recall: Infusion Pump Software
Safety Communication: Cardiac Monitor
Guidance: Digital Health Technologies
Industry data on regulatory monitoring
Say they lack sufficient resources to complete all regulatory priorities
MTI Medical Device Regulatory Report 2024 (n=700)
Lack confidence in their current quality management system
Greenlight Guru State of Medical Device Industry 2025 (n=536)
Increase in FDA device warning letters, FY2023 to FY2024 (24 to 47)
FDA.gov enforcement data (24→47 letters)
How it works
Continuous polling captures every alert the moment it's published.
SHA-256 hashing and immutable storage create a tamper-evident record.
Email digests plus a shared dashboard with exportable audit reports.
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)
Increase in FDA medical device warning letters
FDA.gov enforcement data, FY2023–FY2024 (24→47 letters)
Problem #2
Regulatory professionals report spending 3–8 hours per week on alert collection, not analysis. Headcount stays flat while the scope of post-market surveillance requirements expands.
79% of medical device regulatory professionals report insufficient resources to complete all priorities.MTI Regulatory Report 2024 (n=700)
How ComplianceBrief solves it
Automated monitoring
Eliminates manual website checks and inbox triage.
3–5 hours back / 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 by reference 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 is a tool that supports compliance workflows. It does not guarantee FDA compliance or replace your Quality Management System.
The difference
Before
After
Time saved: 2.5 hours per week · 130 hours per year per person
Product
Live today, plus what's on the roadmap.
Sample preview. Live features: alerts & archive. Summaries and search are planned.
The FDA has released updated guidance for software as a medical device (SaMD), including new requirements for clinical evaluation and risk management processes. This affects all digital health companies developing AI/ML-based diagnostic tools.
U.S. Food and Drug Administration
View original document →a1b2c3d4e5f6...Cryptographically verified and tamper-proof
Review current SaMD development processes against new FDA requirements
Update risk management documentation for AI/ML diagnostic tools
Schedule compliance team meeting to discuss implementation timeline
Sample preview. Live features: alerts & archive. Summaries and search are planned.
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.
ComplianceBrief is compliance infrastructure. It is not a newsletter or a summary service.
Every regulatory update is SHA-256 hashed at the point of retrieval, timestamped, and stored immutably. The result is an audit-proof archive: each record carries cryptographic proof of when it arrived and that it has not been altered since.
FAQ
Free FDA alerts land in individual inboxes. There is no team visibility, no search, and no proof of systematic monitoring for audits.
ComplianceBrief organizes them into a system that saves time and provides QMS documentation.
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
In transit (TLS) and at rest
Automated FDA MedWatch coverage, team-wide visibility, and cryptographic records your QMS can reference. Free tier available. No credit card required.