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Dedicated Industry Solutions

Purpose-built compliance architectures for high-stakes teams.

Every industry faces unique regulatory friction. Straits replaces fragmented spreadsheets and manual audit prep with unified visual tree structures, prebuilt standard templates, and automated cryptographic dossier generation.

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Industry Coverage

3 High-Stakes Sectors

MedTech, Software & Cybersecurity, Hardware & Electronics

Prebuilt Standards

16+ Global Frameworks

FDA, EU MDR, IEC, SOC 2, ISO

Evidence Integrity

100% Cryptographic Seal

Immutable SHA-256 Merkle Trails

Audit Acceleration

85% Faster Clearance

Zero manual spreadsheet synthesis

Dedicated Solution Hub

Select an industry solution for in-depth technical analysis

Click any solution below to explore the dedicated architecture, workflows, regulatory standards, and sample audit packages.

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Medical Device Quality

Healthcare & MedTech Regulatory Compliance

Lead Persona: Sarah • QA & Regulatory Affairs Director

Automate medical device classification, hazard decomposition, and Notified Body technical dossiers. Accelerate FDA 510(k) clearances and EU MDR certifications.

Supported Regulatory Frameworks:

FDA 510(k) / 21 CFR 820EU MDR 2017/745ISO 13485 QMSISO 14971 RiskIEC 60601-1

Core System Capabilities:

Medical device classification checklists (Class I, Class II, Class III)

Automated regulatory cross-mapping across FDA, EU MDR, and ISO standards

Bidirectional hazard-to-verification traceability under ISO 14971

FDA 21 CFR Part 11 compliant digital quality sign-offs

Instant generation of audit-ready Notified Body technical summaries

Deliverable: EU MDR Technical Documentation & FDA 510(k) Summary Dossier

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Agile CI/CD Compliance

Software Process Auditing & Cybersecurity

Lead Persona: James • VP of Compliance & Engineering

Automate software testing and regulatory process audits with prebuilt IEC templates. Streamline continuous compliance for agile development sprints with zero manual audit preparation.

Supported Regulatory Frameworks:

IEC 62304 Class A/B/CSOC 2 Type IIISO/IEC 27001FDA SaMD GuidanceGDPR

Core System Capabilities:

Prebuilt compliance templates for IEC 62304, SOC 2 Type II, and ISO 27001

Automated CI/CD test evidence ingestion (unit tests, SAST/DAST, branch coverage)

Clause-by-clause cryptographic evidence hash verification

Role segregation: auditors, reviewers, and department leads

Real-time audit planning and automated findings export

Deliverable: Audit-Ready Software Verification Packet & Security Attestation

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Product Safety & Testing

Hardware & Electronics Manufacturing

Lead Persona: Marcus • VP of Hardware Engineering & Lab Operations

Automate hardware testing for laptops, consumer electronics, and automotive subsystems. Construct hierarchical component trees linked to accredited laboratory CB Scheme test reports.

Supported Regulatory Frameworks:

IEC 62368-1IEC 62133 (Batteries)IEC 61000-4-2 ESDCISPR 32 EMCUN 38.3

Core System Capabilities:

Hierarchical component tree mapping (Battery, USB-C PD, Mainboard, RF Shielding)

Automated extraction of lab limits from IECEE CB Scheme test report forms (TRF)

Pass/Fail criteria cross-referencing with raw oscilloscope & thermal readings

Multi-tier bill-of-materials regulatory verification

Tamper-proof hardware compliance certificate compilation

Deliverable: IECEE CB Scheme Test Certificate Package & Safety Dossier

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Cross-Industry Architecture Matrix

How Straits adapts across each compliance vertical

Industry Solution	Lead Auditor	Primary Agency / Standard	Core Visual Element	Automated Deliverable	Action
Software & Cybersecurity	James (VP Compliance)	IEC 62304 • SOC 2 Type II • ISO 27001	Prebuilt IEC Template Matrix	Continuous CI/CD Evidence Seal	View →
Healthcare & MedTech	Sarah (QA & Reg Director)	FDA 510(k) • EU MDR • ISO 14971	Device Class Readiness Gauge	Notified Body Technical Dossier	View →
Hardware Manufacturing	Marcus (VP Lab Operations)	IEC 62368-1 • IEC 62133 • CB Scheme	Laptop Subsystem Tree Canvas	CB Scheme Test Report Form (TRF)	View →

Partner Ecosystem & Advisory Network

“At Straits, we believe that great compliance solutions are built on great relationships. Our partners share our commitment to innovation, quality, and delivering real value to the organizations we serve. Together, we combine deep industry expertise across MedTech, life sciences, enterprise software, cybersecurity, and electronics manufacturing to help our clients navigate complex regulatory landscapes with confidence.”

Straits Compliance Governance Board

Ready to streamline your regulatory workflow?

Speak with an industry specialist to configure your organization's tree structure, compliance templates, and automated report pipelines.

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