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Technical File Assessment

Leading comprehensive reviews of innovative device dossiers, successfully translating advanced clinical data, cybersecurity parameters, and biocompatibility profiles into robust regulatory submissions.

Built for Teams Preparing Authority-Ready Documentation

We assess technical files for medical devices and IVDs to identify documentation gaps, regulatory risks, and submission readiness issues before authority review.

Medical Device Manufacturers

Validate that your technical documentation supports safety, performance, and intended use claims.

IVD Companies

Review analytical, clinical, labeling, and performance evidence against applicable requirements.

International Market Entrants

Assisting MD manufacturers in entering international markets by ensuring adherence to global regulatory standards.

Regulatory Affairs Teams

Get an independent review before submission, renewal, variation, or market expansion.

Technical File Review Capabilities

Focused assessment of the documents authorities expect to see when evaluating safety, performance, quality, and regulatory conformity.

Document Completeness Review

Check whether required technical file sections, evidence, declarations, certificates, and supporting documents are present and traceable.

Regulatory Gap Analysis

Compare the current file against SFDA, GCC, and selected international expectations to identify missing or weak elements.

Risk and Clinical Evidence Check

Review risk management, clinical evaluation, performance evidence, and benefit-risk alignment for consistency.

Labeling and IFU Assessment

Assess labels, instructions for use, symbols, claims, language needs, and market-specific information requirements.

Submission Readiness Advisory

Prioritize corrections and prepare a practical action plan before authorization, renewal, or variation submission.

How We Work

A concise assessment process to move your technical documentation from scattered evidence to a clear, submission-ready file.

Collect

Gather technical documents, certificates, labels, test evidence, and previous regulatory files.

Review

Assess file completeness, consistency, claims, evidence quality, and market-specific requirements.

Identify

Document gaps, weak evidence, formatting issues, and authority questions that may delay review.

Prioritize

Rank corrective actions by regulatory risk, submission impact, and implementation effort.

Prepare

Support updates that make the file clearer, stronger, and ready for authority interaction.

Key Deliverables

Clear outputs that drive compliance, reduce risk, and accelerate your time to market.

01

Technical File Gap Report

A structured list of missing, weak, inconsistent, or non-aligned file elements.

02

Submission Readiness Scorecard

A clear view of current readiness across documentation, evidence, labeling, and QMS links.

03

Regulatory Action Roadmap

Prioritized corrective actions for SFDA, GCC, or selected international market requirements.

04

Labeling and Claims Review

Assessment of labels, IFU, claims, symbols, and market-specific content requirements.

05

Evidence Traceability Matrix

Mapping between claims, standards, risk controls, test reports, and supporting evidence.

Build a Complete Regulatory Ecosystem .

LexoraMed provides integrated regulatory support across Saudi Arabia, GCC, and global markets — helping manufacturers move from strategy to authorization with confidence and clarity.

Medical Device Market Authorization

Advisory on securing MDMA, SFDA approvals, and global authorization pathways for regional and international market entry.

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Technical File Assessment

Leading comprehensive reviews of innovative device dossiers, successfully translating advanced clinical data, cybersecurity parameters, and biocompatibility profiles into robust regulatory submissions.

Read More

Post-Market Surveillance

Ongoing compliance, vigilance, safety monitoring, reporting, and lifecycle support after market authorization.

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Frequently Asked Questions

Clear answers to the most common regulatory and compliance questions manufacturers ask before entering Saudi Arabia and global markets.

When should a technical file assessment be done? +
It is best before submission, renewal, variation, market expansion, or after major design, labeling, supplier, or evidence changes.
Can you assess files prepared for CE or FDA markets? +
Yes. We can review existing CE, FDA, or global documentation and map the gaps for SFDA, GCC, or other target markets.
Do you only check document completeness? +
No. We review completeness, consistency, claims, evidence strength, labeling, risk alignment, and submission readiness.
What do we receive after the assessment? +
You receive a structured gap report, readiness view, and prioritized action roadmap for correcting the technical file.