Agentic Intelligence
for Certification

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Compliance busywork drains momentum

Manual evidence pulls. Screenshots. Spreadsheets. Endless auditor Q&A. Your team spends time proving security instead of building and selling.

CCF

138

Technical

Documentation

Annex II/III Compliance

Review Evidence

  • Risk Analysis

  • Critical Evaluation

  • Access Readinees

Review Evidence

  • Risk Analysis

  • Critical Evaluation

  • Access Readinees

Request missing

docs

from provider

Problem

Every delay in compliance costs you 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.

Reply

Forward

Lost this quarter

LumenBridge Co

$1,300,000

Closed Lost

Reason: Compliance

RelayStack GmbH

€350,000

Closed Lost

Reason: ISO 27001 delay

Conformo automates compliance busywork, saving you hundreds of hours.

Get back to what makes your business better and leave the compliance to Conformo's AI agents.

Measurable impact on operations

Measurable impact on operations
21.2%

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.

5.8%

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.

7.3%

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

Our Process

Our Simple, Smart, and Scalable Process

We design, develop, and implement automation tools that help you work smarter, not harder

#

REQUIREMENT

EVIDENCE SOURCE

STATUS

1

Name of the manufacturer and address of its registered place of business covered by the quality management system

Chapter 2 - Actors & External Sources.pdf

Found

2

If the manufacturer’s application is submitted by its authorised representative, the name and address of that representative shall be provided.

Chapter 6 - EC Declaration and Conformity.pdf

Partial

3

4

5

SUMMARY

312

Total

186

Evidence Found

47

Partial

AI Completeness Check

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

AI Assistant

567 documents loaded - 11,433 pages indexed

Find clinical evaluation information and whether it complies with MDR

Clinical evidence was generated via literature review on the equivalent device and state of the art analysis.

• Equivalence based on biological, technical and clinical characteristics

• Literature review conducted covering 5-year period

AI Assistant

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

#

REQUIREMENT

EVIDENCE SOURCE

STATUS

1

Name of the manufacturer and address of its registered place of business covered by the quality management system

Chapter 2 - Actors & External Sources.pdf

Found

2

If the manufacturer’s application is submitted by its authorised representative, the name and address of that representative shall be provided.

Chapter 6 - EC Declaration and Conformity.pdf

Partial

3

4

5

SUMMARY

312

Total

186

Evidence Found

47

Partial

AI Completeness Check

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

AI Assistant

567 documents loaded - 11,433 pages indexed

Find clinical evaluation information and whether it complies with MDR

Clinical evidence was generated via literature review on the equivalent device and state of the art analysis.

• Equivalence based on biological, technical and clinical characteristics

• Literature review conducted covering 5-year period

AI Assistant

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

AI Suggested Findings

4 potential non-conformities

NC-001

Major

Design verification records incomplete for software module

IEC 62304:2006, Clause 5.7

NC-002

Minor

Calibration records for measurement equipment expired

ISO 13485:2016, Clause 7.6|

AI Non-Conformity Identification

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

Audit Plan

Process Records

Findings Log

Interview Notes

ISO 9001 Audit Report

Generating...

AI Report Generation

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

AI Suggested Findings

4 potential non-conformities

NC-001

Major

Design verification records incomplete for software module

IEC 62304:2006, Clause 5.7

NC-002

Minor

Calibration records for measurement equipment expired

ISO 13485:2016, Clause 7.6|

AI Non-Conformity Identification

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

Audit Plan

Process Records

Findings Log

Interview Notes

ISO 9001 Audit Report

Generating...

AI Report Generation

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

Benefits

The Key Benefits of AI for Your Business Growth

Discover how AI automation enhances efficiency, reduces costs, and drives business growth with smarter, faster processes.

End-to-end encryption

Data protected at rest and in transit with robust, industry-standard encryption protocols.

Multi-model architecture

Leverage the best AI models from OpenAI, Anthropic, and Google—automatically optimized for each task.

24/7 Availability

AI-powered systems operate around the clock, ensuring seamless support and execution without downtime.

Cost Reduction

AI automation minimizes manual work, cuts operational costs, and optimizes resource allocation for better profitability.

Data-Driven Insights

Leverage AI to analyze vast data sets, identify trends, and make smarter, faster, and more accurate business decisions.

Scalability & Growth

AI adapts to your business needs, allowing you to scale efficiently without increasing workload or costs.

Don't let manual compliance slow you down.

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© All right reserved