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Document Intelligence for Pharma & Medical Devices

Pharma and medical device companies manage extensive design history files, supplier certifications, and regulatory documentation , and design control deficiencies were cited in 25 of 44 FDA warning letters last year. Customiser's AI agents extract structured data from DHF documents, verify design traceability, map compliance against FDA and ISO requirements, and surface documentation gaps before auditors find them , reducing audit preparation time and protecting your regulatory standing.

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How teams use Customiser

Extract DHF documents, verify design traceability, map regulatory compliance, and accelerate audit readiness.

DHF Document Extraction

Extract structured data from design history file documents , design inputs, outputs, verification results, and validation records. Customiser processes diverse DHF formats and organizes the data so your quality team can review design completeness without manually combing through hundreds of pages.

Design Traceability

Trace design inputs through to outputs, verification, and validation to verify full requirements coverage. Customiser maps each requirement to its corresponding design output, test result, and validation evidence, highlighting gaps in the traceability matrix automatically.

Supplier Cert Verification

Verify supplier certifications , ISO 13485 certificates, biocompatibility reports, sterilization validations , against your approved supplier requirements. Customiser checks expiration dates, scope coverage, and certification standards, flagging any non-conformances before they affect production.

Regulatory Compliance Mapping

Map your design documentation against regulatory requirements from FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable standards. Customiser identifies which requirements are covered, which need additional evidence, and where documentation gaps exist for audit readiness.

Automated Supplier Qualification Document Processing

Ingest supplier qualification packages , quality certifications, audit reports, quality agreements, capability assessments , and automatically extract certification details, scope, expiration dates, and audit findings. Customiser cross-references against your approved supplier requirements to flag gaps or expired certifications, turning a multi-week review into a structured, automated workflow.

Post-Market Surveillance Report Compilation

Extract and structure data from complaint databases, adverse event forms, and clinical literature for regulatory reporting. Customiser aggregates post-market data into the format required for Periodic Safety Update Reports and Post-Market Surveillance Reports under EU MDR and FDA guidance, significantly reducing the manual effort of surveillance report compilation.

Pharma & Medical Devices FAQ

Customiser parses DHF documents to extract design inputs, design outputs, verification protocols and results, and validation records. It organizes this data into structured summaries that make it easy to assess design completeness and identify documentation gaps , critical for avoiding the DHF deficiencies that are among the most common FDA warning letter findings.
Design traceability verification maps each design input through to its corresponding design output, verification test, and validation evidence. Customiser builds and validates the traceability matrix automatically, highlighting any requirements that lack complete coverage , ensuring the bidirectional traceability that FDA expects during inspections.
Yes. Customiser checks supplier certificates against your qualification requirements , verifying scope coverage, applicable standards, expiration dates, and accreditation body validity. Non-conformances are flagged immediately so your supplier quality team can take corrective action before gaps affect production or trigger regulatory citations.
You select the applicable regulatory standards , FDA 21 CFR 820, ISO 13485, EU MDR, ISO 14971 , and Customiser maps your existing documentation against each requirement. It identifies covered areas, missing evidence, and documentation gaps, giving your regulatory team a clear audit-readiness picture and helping prioritize remediation before inspections.
Design control deficiencies under 21 CFR 820.30 were cited in 25 of 44 FDA warning letters last year, alongside CAPA system issues and complaint file problems. Common document control failures include using unapproved documents, failure to maintain records, and inadequate change control. Customiser helps prevent these by ensuring every document is classified, version-controlled, and traceable with automated completeness checks.
The FDA's QMSR, incorporating ISO 13485:2016 by reference, requires companies to align their quality systems and documentation with ISO 13485. Customiser accelerates this transition by ingesting existing quality system documents, extracting their content, and mapping them against ISO 13485 clause requirements , identifying where documentation does not address ISO 13485 requirements or where terminology needs updating.
FDA warning letters are public and damage reputation. Consent decrees can shut down manufacturing entirely. 483 observations require formal response within 15 business days, diverting resources from development. Remediation of a deficient quality system typically costs $2-10 million and takes 12-24 months. Customiser provides continuous visibility into document completeness, catching gaps during development rather than during an audit.
Yes. Customiser can extract structured risk data from risk analysis worksheets, FMEA documents, and risk management reports , pulling hazard descriptions, severity ratings, probability scores, and control measures into a structured format. This data can be cross-referenced against design verification records to confirm all risk controls have been implemented and verified, supporting the comprehensive risk documentation that ISO 14971 requires.

No manual reviewing.
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