The world's leading automated proofreading software
Prevent Errors in IFUs, DFUs, Manuals, Cartons and Labels in Medical Devices—Before They Impact Patients
Ensure compliance, eliminate errors, and accelerate approvals—TVT is trusted by leading medical device manufacturers worldwide.
The Cost of a Single Error
In the medical device industry, there’s no margin for mistakes. Even a small documentation error—like an untranslated warning or misaligned UDI—can compromise patient safety and block market access.
Do these challenges sound familiar?
Manual proofreading eats up hours—and still lets errors slip through.
Regulatory scrutiny is relentless. FDA, EMA, MHRA and other global authorities allow no inconsistencies.
Multilingual and multi-format content increases risk. IFUs, eIFUs, labels, barcodes, and Medical Device Symbols must align perfectly.
Product documentation constantly evolves. Each revision adds complexity—and potential for error.
Meet TVT—Purpose-Built for Medical Devices
TVT by Schlafender Hase is the automated proofreading solution designed for life sciences. It ensures accuracy, consistency, and compliance across all medical device documentation.
With TVT, you can:
Trusted by Global Medical Device Leaders
TVT is trusted by leading medical device manufacturers and regulatory teams worldwide.
TVT: Built for Pharma
ISO 9001:2015 and ISO 27001 certified
GAMP® 5-complaint and easy to validate
Facilitates Compliance with FDA 21 CFR Parts 820.40 & 820.120, EU MDR and IVDR.
Facilitates compliance with accessibility laws (e.g., Section 508, EAA)
What Our Clients Say
With the implementation of TVT in its quality assurance department, New World Medical is achieving significant time savings. It now also plans to roll out the automated proofreading solution from Schlafender Hase across other parts of the company.
New World Medical: Increased Efficiency and Language Translations
“Our intention had been to really find the perfect automated proofreading solution for our company, and once we did, we wanted to move forward as quickly as possible so we can really save resources and improve time management for our proofreaders. TVT will really help us in our current expansion into more countries and regions, especially for verifying IFUs in multiple languages.”Kejdi Tafili, Senior Regulatory Affairs Specialist
See TVT in Action
Watch how TVT automates medical device proofreading across every document type.
Want a personalized tour? Book Your Full Demo to see TVT on your actual files.
Manual Proofing vs. TVT: Why Manual Proofing No Longer Measures Up
| Task | Manual Proofing | With TVT |
|---|---|---|
| Proofing Time | Several hours | Minutes with automation |
| Languages Handled | Manual, one at a time | Automatic multilingual support |
| Barcode & UDI Checks | Manual decoding | Built-in barcode validation tools |
| Regulatory Alignment | Time-consuming, fragmented | Streamlined, audit-ready |
| File Formats Supported | Limited | PDF, Word, Excel, XML, HTML |
See TVT in Action—Tailored for Medical Devices
Discover how TVT simplifies documentation review and reduces compliance risk across your device lifecycle.
Your personalized demo includes:
A customized walkthrough of TVT’s core features
Real-world medical device documentation scenarios
Expert answers to your regulatory and validation questions
Frequently asked questions
Yes. TVT is designed to help medical device companies meet the stringent documentation and labeling requirements in the EU MDR and IVDR, as well as FDA & EMA regulations.
Absolutely. TVT supports detailed comparison of IFUs, DFUs, eIFUs, and UDI data—including barcodes and multilingual content.
Most teams are fully operational within a few weeks. We provide onboarding support, validation documentation, and an e-learning portal.
Yes. TVT can be integrated with most CMS, QMS,PLM and Authoring systems used in the medical device industry.
Need more answers? Book a demo and we’ll walk you through it.
Improve Accuracy. Streamline Compliance. Get to Market Faster.
Join the leading medical device companies who trust TVT.
