Straits
AI-Driven Audit Assistance
Just as a strait connects two water bodies to maintain uninterrupted flow in nature, Straits connects people, processes, and compliance frameworks, removing manual bottlenecks and ensuring smooth organizational audits.
Continuous Traceability
Multi-tier clause mapping connecting engineering requirements to verification evidence.
Automated Attestation
Cryptographic audit trails eliminating manual spreadsheets, review lag, and human error.
Multi-Framework Sync
Harmonize FDA 510(k), EU MDR, ISO 27001, and SOC 2 into unified compliance trees.
Auditor Review Portal
Instant visual roadmap giving notified bodies and auditors transparent, scoped access.
Visualize Complex Processes
Our Smart Editor transforms intricate compliance workflows into clear, manageable tree flowchart structures. Deconstruct multi-layered requirements, map dependencies with complete confidence, and give auditors an intuitive visual roadmap of your entire quality ecosystem.
Enterprise Quality & Compliance Master Plan
Cryptographically bound to FDA 510(k), ISO 13485 & SOC 2
ISO 13485 QMS
18 ClausesIEC 62304 Software
Class BSOC 2 Controls
ContinuousIntelligent Compliance Platform
Three distinct architectural modules engineered to accelerate attestation and eliminate audit friction.
Seamless Connections
Connect distributed engineering teams, compliance documentation, and regulatory frameworks into a synchronized audit workspace.
Smart Editor for Process Clarity
Deconstruct complex regulatory standards into modular, annotated tree structures. Every clause, checklist, and artifact link is verifiable.
Automated Verification
Verify compliance continuously rather than scrambling before deadlines. Automated checks eliminate review panic and guarantee clean audit outcomes.
Real Life Results & Revenue
A connected, intelligent ecosystem where compliance flows as seamlessly as water. Eliminate pre-audit bottlenecks, slash cycle times, and pass regulatory audits on the first submission.
Speed Improvement
Automated workflows reduce audit preparation cycles
Compliance Precision
AI-driven validation ensures complete clause accuracy
Accelerate Your Regulatory Audits With Automated Traceability
Straits deconstructs high-stakes compliance standards into clear, verifiable requirements. Replace fragmented spreadsheets and chaotic audit preparation with continuous, automated attestation trees.
Continuous Attestation Trees
Break down FDA, ISO, and SOC 2 requirements into automated, verifiable child nodes with direct evidence attachment.
Cross-Framework Synchronization
Update a shared requirement once and synchronize verified attestations across all corresponding regulations instantly.
Instant Auditor Review Portals
Provide external notified bodies and regulatory auditors dedicated, transparent visibility into your entire compliance posture.
Connect With Our Compliance Engineering Team
Have questions about deploying Straits continuous audit infrastructure for your quality and engineering teams? Our regulatory specialists are here to assist.
Response time within 2 hours
Direct onboarding consultation with lead audit engineers
Live demo sandbox access at demo.straits.io