Agentic Intelligence for Certification

Seamflow builds AI-native tools for the TIC industry, turning complex regulatory workflows into scalable operations.

Built by talent from

To-Do

• Review technical file for MDR/IVDR evidence gaps
• Perform completeness checks before assessment
• Schedule surveillance audit across regions

Alert

• Incomplete risk management documentation
• Auditor qualification lapse pending replacement

Notice

• Client escalation: certification date slipping
• Subcontractor budget exceeded for upcoming audits

Operational overhead slows the TIC industry.

Manual document handling, fragmented tools, and constant coordination between reviewers, planners, and auditors create friction at every stage of certification.

MDR 2017/745

CCF

• Technical Documentation

  • Annex II/III compliance
  • Review evidence

• Risk Analysis Uploaded

• Clinical Evaluation Not uploaded

• Biocompatibility Uploaded

• Manual coordination required

  • Request missing docs from manufacturer

Every delay costs you clients and revenue.

Slower execution means fewer certificates issued, higher assessment costs, and growing pressure on margins.

Certificate Revenue

• Declining over last quarter: 23%

Last 90 days

• Oct
• Nov
• Dec
• Jan

Cannot Proceed — Certification Delayed

MedTech Solutions GmbH
compliance@medtech-solutions.de

Dear Certification Team,

Due to the extended timeline on our MDR technical file review, we have decided to move forward with a different Notified Body. Our market window closes in 6 weeks and we cannot wait any longer.

We will be requesting a full refund per our contract terms.

Regards,

Thomas Müller

Lost this quarter

• NovaMed Devices: €340,000
  • Closed lost
    • Reason: Timeline
• BioCert AG: €520,000
  • Closed lost
    • Reason: Capacity
• Alpine Diagnostics: €180,000
  • Closed lost
    • Reason: ISO 13485

Seamflow is the operating system for TIC organizations.

AI agents handle execution tasks, so your experts can focus on technical judgment and certification decisions.

Our Platform

01

Notified Body Suite
From intake to certificate, one operational system.
Not a reviewer add-on, an end-to-end platform covering intake, client portals, pre-checks, technical review, decision making, and audit trails.

We model your real regulatory workflows and produce a complete, auditable record.

Workflow Overview

• 52 active
  • Intake: 3
  • File Review: 4
  • Final Review: 2
  • Decision: 1
• 52 Active
• 137 Completed
• 71 Pending
• 78%

02

Scheduling Agents
Scheduling that works like an operations team.

• Automatically reach out to freelance auditors to confirm availability
• Apply your own assignment and rotation rules, enforced automatically
• Check travel routes, flight availability, and on-site feasibility
• Match niche competence and regulatory scope

All while enforcing competence, impartiality, and independence by default.

Weekly Planner

AI: Optimize: Move Wed audit → save 45km travel

03

Tech File Review
Tech File Review, one controlled review workflow.
Not a document reader, a structured review system covering file intake, evidence mapping, gap identification, reviewer input, and final technical conclusions.

We structure technical documentation against applicable requirements and produce a complete, traceable, auditable review record.

AI Analysis

• IEC 62368
• AV & IT Equipment
• UL Standards
• Safety Certification
• CE Marking
• European Conformity
• ISO 17025
• Testing & Calibration
• ISO 9001
• Quality Management
• 4.1 Context of Organization
• 5.1 Leadership Commitment
• 6.1 Risks & Opportunities
• 7.1 Resource Management
• 8.1 Operational Control
• 9.1 Performance Evaluation
• 10.2 Corrective Actions

Generate Report

Outcomes

Measurable impact on operations

• 50.9%: Less Time Spent per Technical Assessment
  Automated completeness checks, evidence structuring, and AI-assisted report drafting reduce manual effort across pre-check and review preparation, lowering assessment cost per certificate.

• 25.6%: Higher Assessment Throughput per Team
  Review teams complete more assessments over time by focusing on technical judgment instead of document navigation and manual coordination, increasing revenue capacity without linear headcount growth.

• 20.3%: Higher Internal Auditor Utilization
  Qualification-aware scheduling improves use of internal auditors before relying on subcontractors, without compromising independence rules, improving margins by shifting work in-house.

Integration Hub

All systems connected

How We Work

Implementation that adapts to you

Deployment happens in close partnership with your certification, quality, and IT teams, using your real data, real processes, and real constraints.

1. Integrate with Existing Systems
   We connect Seamflow to your document management systems, QMS, ERP, and identity infrastructure, working within your existing IT and security constraints.
2. Model Your Certification Rules & Structure
   We configure regulatory scopes, standards, roles, independence rules, and approval flows to match how your organization actually operates.
3. Deploy AI Where It Adds Leverage
   AI is embedded directly into pre-checks, technical review, quoting, reporting, and scheduling, supporting execution without bypassing controls.
4. Human-in-the-Loop by Design
   All AI outputs are reviewable, explainable, and auditable. Final technical judgments and certification decisions always remain with authorized personnel.
5. A Partnership, Not a Project
   Implementation isn't the end. We work alongside you to continuously tune, optimize, and expand Seamflow as your needs evolve.

Capabilities

The AI-native TIC platform

Seamflow embeds AI across the entire TIC workflows, accelerating every stage of regulatory review while preserving traceability and control.

AI Completeness Check

Checks technical documentation against applicable standards and scope to identify missing evidence and readiness gaps before review.

AI TD Assistant

Supports technical reviewers by navigating large technical files, cross-checking evidence, and highlighting inconsistencies during assessment.

AI-Supported Quoting

Supports consistent and traceable quotations by evaluating certification scope, complexity, and expected assessment effort.

AI Non-Conformity Identification

Identifies and structures potential non-conformities and observations with traceability to requirements, evidence, and corrective actions.

AI Report Generation

Generates structured drafts for technical assessment reports and certification decisions aligned with findings and accreditation requirements.

Enterprise Grade Security

Built for regulated industries

ISO 27001 certified

Internationally recognized information security management with continuous compliance monitoring.

GDPR compliant

Full data sovereignty with EU hosting options and transparent data processing agreements.

Enterprise controls

• SSO integration, granular permissions, and detailed audit trails for complete oversight.
• End-to-end encryption
  Data protected at rest and in transit with industry-standard encryption protocols.
• Multi-model architecture
  Leverage the best AI models from OpenAI, Anthropic, and Google—automatically optimized for each task.
• Continuous validation
  Automated quality checks ensure AI outputs meet accreditation standards before delivery.

Ready to Transform?

See Seamflow in Action

Discover how our AI-powered platform can streamline your regulatory workflows and accelerate approvals.

BOOK A DEMO