Documentation that withstands scrutiny.
We engineer precise, citation-accurate technical files, regulatory dossiers, and operating manuals for AI companies, aerospace systems, and defense contractors. Audit-ready from the first draft.
Cited Workflows
500+
High-Stakes Audits Passed
Response SLA
48 Hours
Guaranteed Intake
Success Value
100%
Regulator Clearance Rate
Rigorous documentation systems tailored for highly regulated sectors.
AI Regulatory & Compliance Engineering
Rigorous technical files and Article 9 risk management systems structured directly for statutory auditing.
- EU AI Act (Annex IV) technical documentation dossiers
- ISO/IEC 42001 (AIMS) setup and readiness audit files
- Algorithmic impact assessments and validation logs
- Model governance, drift logs, and lifecycle schemas
Government Tenders & Grant Writing
Highly structured RFP responses and scientific grant proposals aligned precisely to scoring metrics.
- Requirement-to-response technical mapping matrices
- Defense and civil procurement bids (RFP/RFI/RFQ)
- Horizon Europe, Innovate UK, and SBIR grant bids
- Executive summaries and system architecture descriptions
Aviation & Safety Manuals
Operational manuals and maintenance expositions engineered to EASA, FAA, and ICAO regulations.
- Maintenance Organisation Expositions (MOE Part-145)
- Flight Operations Manuals (OM Parts A, B, C, & D)
- Safety Management Systems (SMS) design and filing
- Continuous Airworthiness Management (CAMO) standards
Audit-Ready Engineering Dossiers
Detailed specifications, safety cases, and architecture manuals prepared for high-stakes audits.
- IEC 62304 Medical Device software lifecycle reports
- DO-178C / DO-254 avionics software and hardware assurance
- ISO 26262 automotive functional safety technical logs
- NASA-STD-8739 critical software architecture audits
Our Proven Drafting & Audit Methodology
We work as embedded regulatory engineers. Rather than generic templates, we create system-specific compliance files citing direct regulatory frameworks.
Deconstruct the System Architecture
Our engineers extract data models, system logs, code architecture, and regulatory mandates directly from your technical team to map out the entire operational footprint.
Key Deliverables:
- Structural system boundary reports
- Regulatory gap analysis logs
- Citation mapping database setup
Synthesize the Audit Dossiers
Surgical Review & Integrity Validation
Regulated environments require domain expertise.
Artificial Intelligence
Technical files and model governance reports for foundation models and high-risk AI applications.
Aerospace & Avionics
Operational manuals and safety expositions for Part-145, Part-CAMO, and UAS/eVTOL operators.
Defense & Government Bids
Technical bidding narratives, military spec compliance, and secure tenders.
Healthcare & MedTech
Software lifecycle documentation, risk management logs, and clinical safety declarations.
Framework Expositions We Maintain
Direct mapping of compliance criteria to verify operational systems against globally recognised legislation.
EU AI Act
Artificial Intelligence
ISO 42001
AI Management System
ISO 27001
Information Security
IEC 62304
Medical Device Software
DO-178C
Avionics Software Assurance
FDA 510(k)
Medical Devices Bids
MDR 2017/745
European Medical Devices
HIPAA Security
Protected Health Info
SOC 2 Type II
Trust Services Criteria
CQC Standards
Care Quality Assurance
Proven Regulatory Clearances
Volatus Aerospace Technologies
Defense & Autonomous Aviation
100%
First-Pass FAA Approval
$18.4M
Government Contract Won
The Challenge
Deliver FAA-compliant Safety Cases and UAS Operation Expositions under strict deadlines for defense procurement.
The Solution
ComplDoc mapped the UAV propulsion system and software control loops directly to DO-178C objectives, authoring 1,200 pages of audit-ready technical briefs.
“ComplDoc transformed a chaotic compliance risk matrix into a perfectly typeset regulatory dossier, satisfying the external audit committee within hours of receipt.”
MedGen AI Diagnostics
Healthcare / Medical AI
3 Weeks
Documentation Delivery
Zero
Auditor Corrective Actions
The Challenge
Complete ISO 42001 and IEC 62304 compliance files for a neural-network-based oncology screening tool.
The Solution
Configured Article 9 AI Risk Registers, technical specifications of training pipelines, and dataset provenance matrices mapped to FDA guidance.
“ComplDoc transformed a chaotic compliance risk matrix into a perfectly typeset regulatory dossier, satisfying the external audit committee within hours of receipt.”
Consistently aligned to rigorous mandates.
Empirical compliance reports generated by our system pass regulator evaluations on first submittal.
EASA File Accuracy
100%
Tender Score Ratio
94.8%
Audit Satisfaction
99.2%
Trusted by procurement directors and compliance leads.
“ComplDoc drafted our maintenance organization exposition for EASA Part-145 approval. Their technical writers understood the regulatory text better than our engineering team. An absolute masterpiece.”
Antoine Varin
Head of Safety Expositions, Aviate Global Ltd
“We secured a $12M municipal transit tender on our first bid attempt. ComplDoc’s requirement mapping matrices allowed us to address every scoring criterion with clinical precision.”
Dr. Diana Boyd
Bid Director, Transit Tech Systems
Ready to structure your regulatory dossiers?
Ensure your documentation is audit-ready and legally robust. Get in touch with our lead regulatory technical engineering experts today.