How do medical device companies manage MDR technical documentation across hundreds of product variants?

Most QM teams copy the same GSPR data points into each product's TechDoc separately. With 2 products, that's workable. With 20, every regulatory update means editing the same content across dozens of files, and version errors accumulate. OPED had dozens of orthopaedic products and variants under EU MDR. They moved their regulatory content into a structured data model: each data point lives once, and every TechDoc reads from it. A regulatory update changes 1 record. Every document stays current.

What's the difference between a document management system and a structured TechDoc platform?

A document management system gives teams a shared place to store files. The TechDoc is still a Word file, edited by hand. CertHub stores each regulatory data point in a database: clinical evaluation, risk analysis, intended purpose, each mapped to every document that needs it. When a data point changes, every document that references it updates.

How does CertHub handle MDR documentation for product families with many variants?

Shared regulatory data, clinical background, intended purpose, applicable standards, is defined once at product or family level. Variants that share a UDI-DI are covered under the same TechDoc; variant-specific data is only entered where it actually differs. When shared regulatory content changes, every document in the family gets the update automatically.

How OPED Automates Technical Documentation

Questions about structured MDR documentation

What QM and RA managers ask most before moving from Word and Excel to a single source of truth.