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Tech File Pre-Screener
Completeness check before human review.
Audit Companion
Real-time AI links to standards during audits.
Reviewer Harmonizer
Suggests NC wording based on precedents.
Decision Builder
Compiles Certification Reports automatically.
Reg. Doc Checker
Gap analysis against MDR Annex II & FDA.
Cross-File Validator
Syncs Risk Management vs. IFU vs. Clinical.
AI Drafting Assistant
Auto-drafts CERs, PMS Reports, FDA Summaries.
Change Impact Analyzer
Detects regulatory impact of BOM changes.
PMS Detector
Scans MAUDE/EUDAMED for adverse events.
Labeling Robot
Checks symbols (ISO 15223) against Risk File.
Input
Legacy Archives, Video, Voice, Tables.
Parsing
Proprietary ADHOCON Script (Unstructured to Machine-Readable).
Cloud
Kubernetes/Docker in Client's Azure/AWS/Google Cloud.
Intelligence
Vectorized Context Search (RAG)
Result
Hallucination-free, citation-backed Output.
THE PIPELINE
REAL-LIFE IMPLEMENTATIONS
AI DRAFTING ASSISTANT
Medical Device Manufacturer
Data
Raw clinical data, previous CERs, Post-Market Surveillance excel sheets, and vigilance databases.
Action
The Agent acts as a Regulatory Writer, synthesizing millions of data points into a compliant Clinical Evaluation Report (CER) draft, citing specific MDR Annex XIV requirements.
Value
Reduces drafting time from 3 months to 2 days. 80% Cost reduction.
CROSS-FILE CONSISTENCY
Medical Device Manufacturer
Data
Risk Management File (ISO 14971), Instructions for Use (IFU), and Clinical Evaluation.
Action
The Agent cross-references every risk identified in the Risk Table against the warnings in the IFU and the claims in the Clinical Evaluation to find discrepancies.
Value
Eliminates common Notified Body findings regarding inconsistent documentation. Zero "Simple" Non-Conformities.
AUDIT COMPANION
Gatekeeper / Notified Body
Data
Live audio stream of the audit conversation, PDF library of ISO 13485, MDR, and company SOPs.
Action
While the auditor speaks, the AI transcribes and suggests relevant regulatory clauses or missing evidence in real-time on the auditor's screen.
Value
Increases audit depth and confidence. Ensures no critical requirement is overlooked during the on-site visit.
DECISION DOSSIER BUILDER
Gatekeeper / Notified Body
Data
Reviewer notes, checklists, and raw technical file assessment reports.
Action
The Agent compiles scattered reviewer notes into a formal, legally binding Certification Decision Report and drafts the Non-Conformity Letter automatically.
Value
Standardized decision output across all reviewers globally. Reduces administrative overhead by 90%.
ELECTRICIAN OFFER AUTOMATION
SME Use Case
Data
Wholesale catalog APIs (current prices), customer measurements, and historical accepted offers.
Action
The Master inputs rough measurements. The AI selects the best materials based on margin, calculates labor, writes a customer-friendly proposal, and prepares the invoice.
Value
Offers go out in minutes, not weekends. Higher win-rate due to speed.
DIGITAL HEALTH TWIN
Personal AI Use Case
Data
Scattered PDF doctor's letters, DICOM X-Ray images, Apple Health/Garmin vitals, blood work history.
Action
The AI runs locally (privacy first), structuring the medical history into a timeline, predicting health risks, and suggesting lifestyle changes based on longevity science.
Value
Proactive health management. The user owns their medical truth, independent of scattered doctors.
SCHOOL & KINDERGARTEN BOT
Education Use Case
Data
School regulations, curricula, FAQs, previous parent letters.
Action
Generates instant parent communications, drafts development protocols for students, and creates creative assets (coloring pages/mandalas) for class.
Value
Relieves teachers from bureaucracy. More time for the children.
TRUST & BADGES
ISO
13485
compliant
ISO
17024
EXPERT
ISO
22301
RESILIENCE
MULTI- CLOUD
DEPLOYMENT
OPEN SOURCE & INFRASTRUCTURE
Library
Public
MIT License
Compliance-Ready
10,000+ Validated Prompts for MedTech/Pharma. Compliance by Design.
2
1
1
0
Github
Public
PDF Parsing
Developer Tool
PDF to JSON Converter for Regulatory Docs.
2
1
1
0
SMTP250.org
Service
Public
Infrastructure
Secure Messaging
Secure, validated messaging backbone for critical operations.
0
0
1
0
Library
Public
MIT License
Compliance-Ready
10,000+ Validated Prompts for MedTech/Pharma. Compliance by Design.
2
1
1
0
Github
Public
Automated Alerts
Regulatory Signals
GitHub
Public
PDF Parsing
Developer Tool
Service
Public
Infrastructure
Secure Messaging
REGULATORY AFFAIRS
CODING
DIGITAL TWINS
SME AUTOMATION
CRISIS PREPARATION
INFRASTRUCTURE
ARTIFICIAL INTELLIGENCE
FOR EVERYONE.
VALIDATED FOR THE BEST.
USEFUL AND TRUTHFUL.
Automating the routine, augmenting the expert. We activate the native AI capabilities you already own in Azure, AWS, and Google Cloud. Zero overhead. 100% compliant.