Regulatory Document Knowledge Mining and OCR for an Ophthalmic Device Manufacturer
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Problem
Decades of paper records
An ophthalmic device manufacturer operating across 12 sites and markets held decades of regulatory submissions, quality-system records and test reports on paper and scanned PDFs. Audit preparation meant days of manual retrieval from filing rooms, renewal submissions were rebuilt from scratch each cycle, and the institutional knowledge inside those documents was effectively invisible to current regulatory staff.
Solution
Searchable OCR knowledge repository
We built an OCR and knowledge-mining pipeline: bulk scanning intake, layout-aware text extraction, automated classification across regulatory document types, and entity extraction of device models, markets, submission types and key dates. Everything lands in a searchable repository with semantic search over the full corpus, and a human review loop continuously corrects and retrains the classifiers.
Measurable Impact
What changed after launch
Over 480,000 pages of regulatory and QMS records digitised and classified within 7 months
Document retrieval during audits cut from an average of 2 days to under 5 minutes
96% classification accuracy across 14 regulatory document types after review-loop tuning
Renewal submission preparation time reduced by roughly 35% across the 12 markets
Tech & Tools Used
What powered the build
Ready to Build your Medical Devices Business with Knowledge Mining & OCR
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