Error-proof your medical device labeling and packaging
Get content ready for launching across markets, faster. Proof complex documentation with fewer revision cycles.
- Automate manual tasks, from project setup to reporting
- Conduct many-to-one text checks for multilingual documents
- Prevent costly recalls due to package and labeling errors
Regulatory authorities rely on TVT:
These companies use TVT to run content comparison for medical device documentation across multiple languages:
Labeling and IFU verification without the right tools is like running an extreme obstacle course
You need to launch across markets fast, but can’t afford to have errors in translated content.
So you end up going through multiple revisions rounds before making it to the finish line.
Complex documentation
Complex tables, multi-page documents and e-labeling require special attention to prevent errors.
Cross-functional verification
Manual reviews across departments can add days or even weeks to your launch timeline.
Global compliance needs
The growing number of regulations means extra workflow steps to stay compliant.
Use TVT to power up your content verification process for medical device documentation
Boost your proofreading accuracy and review speed. Without having to adapt your process to a new tool.
Catch all deviations. At once. In one list.
Combine TVT with add-ons to leave the workflow chaos behind. Instead, get all checks completed, all at once.
Support for all teams involved in review
Effortlessly import and review changes made by every team, from RA to translators. And be sure no update is overlooked.
Full compliance. No slowing down.
Use TVT to check for compliance with submission format, medical device labeling and unique device identifier requirements.
Make catching changes and making updates across languages and departments a walk in the park
Bunny-proof all content verification steps before publication. From submissions to barcodes.
We never cherry-pick files to make TVT look good.
Send us your most complex files and we'll use them during the demo.
Supports reviews across multiple document types and formats
Use TVT to tackle multiple tasks across all content review stages.
- Supports any language using Unicode fonts, including right-to-left scripts and Braille.
- Detects differences in layout, formatting, reading order, symbols, hidden characters and spacing.
- Supports comparison between different file formats and multi-language files, even for different layouts
- Catches errors in number and unit formatting, repeated words, font style changes and more.
Quickly uncovers all deviations across files. So you can approve or reject them.
Detect deviations, export and reimport comments, and redline changes. Plus, find artwork and even barcode errors.
- TVT detects reading order changes, character and symbol errors and more, even in complex tables and long documents
- TVT Spelling catches spelling errors, including in languages you don’t speak (or read)
- TVT Artwork runs layer-by-layer and pixel-by-pixel comparison of printer’s proof packaging files
- TVT Barcode ensures barcode compliance and scannability without print order recalls
Build your compliance safety net. Without added admin.
Regulatory standards. Reporting requirements. E-labeling compliance. All covered by TVT features and settings.
- Facilitates compliance with 21 CFR Part 820
- Supports EU MDR compliance for medical device labels and eIFU, IFU, and DFU manuals
- Supports SPL submission format
- Provides a clear audit trail and automates report generation
Build a fully compliant process with every step in one place
Instead of juggling separate tools and workflows, complete all review steps inside TVT.
Get signoffs faster and never worry about breaks in your audit trail.
Publication-ready documents are just a hop and a skip away
See how our customers complete content verification faster, with fewer revisions
(imagine checking IFUs in one hour instead of ten)
“The number of correction cycles was significantly reduced”
Now Lohmann & Rauscher team can review large, multi-language user instructions files in one hour instead of ten.
Michael Breiler
Director of Packaging Development“It was exactly what we needed”
Biomapas saves 1 to 2 days per piece during packaging review, supporting pharma, biotech and medtech companies across 64 countries.
Lina Kaušakienė
Regulatory Affairs Project ManagerHow is TVT different from other solutions?
TVT was built for highly regulated industries, such as medical devices, to make complex content verification error-proof.
Read more about the TVT difference, plus find answers to other common questions.
Book your demo
How is TVT different from other content verification solutions?
TVT helps teams in highly regulated industries automate content verification while staying compliant. It can compare files across different file types, for example, PDF to Word, run one-to-many content comparisons and handle complex layouts, including tables, in all languages that use Unicode encoding.
TVT is configurable, which means that it doesn’t produce high numbers of false positives. It also supports bulk actions and shortcuts, speeding up reviews for TVT power users (and any user that has watched our e-learning video content).
Our solution is especially popular with life science industries: it is used by 20 out of top 20 pharma companies. And it’s the only solution used by 5 health authorities around the world.
What is the difference between the TVT software and the TVT add-ons?
TVT software can help you compare documents across different file formats and detect the following changes:
● word and reading order, including in complex tables
● removed or added text
● changes in images, even for files with different layouts
● style discrepancies, such as text font size and styles
● language-specific formatting issues, such as numbers or date formats
TVT Spelling detects spelling mistakes, while TVT detects text deviations (so if your source file has a typo that’s replicated in other documents, it won’t be recognized).
TVT Artwork is specifically designed for printer’s proof artwork verification. It compares graphics pixel by pixel to catch critical issues like color variations, overprinting or misalignment in packaging or labeling materials.
TVT Barcode can be used to automatically detect, decode, and grade barcodes on packaging or in promotional materials.
Which compliance regulations does TVT take into account?
TVT facilitates compliance with FDA regulations (21 CFR Part 11) and EMA regulations (Annex 11).
It helps comply with EU 1169/2011, EC 1223/2009, CLP (EC 1272/2008) & GHS, eCFR:: 40 CFR Part 156 — Labeling Requirements for Pesticides and Devices, Classification, Labeling and Packaging (CLP) Regulation ((EC) No 1272/2008), and MoCRA.
TVT supports QRD, SPL and SPM submission formats, reading order verification for Section 508 (US) and the EU Accessibility Act, EU Regulation No 1169/2011, FHIR XML documents and improved HTML comparison, as well as a new critical words list for food allergens across Europe and the United States.
Does TVT integrate with regulatory, artwork or document management systems?
Yes! Both on-premise and cloud TVT versions can be integrated into your AMS/DMS and regulatory management systems.
Do you offer a free trial?
Yes, you can try out TVT for 1 month with all of your team members. You’ll have access to our implementation experts to get tips on using TVT and have your questions answered.
Sign up for a demo so we can set up a personalized walk-through and kick off your trial.
Do you provide support with validating TVT?
Yes. Every version of TVT is validated prior to release. For companies that need to validate TVT in their own environment, we provide a validation package with IQ, OQ test cases and a protocol to replicate our own validation process .
Validation takes 1-2 days for most customers.
You can also request validation support from our team.
Do you provide onboarding support and training?
Absolutely. TVT comes with comprehensive e-learning and training videos for fast onboarding and GxP compliance. Plus, we offer personalized virtual and on-site training sessions to get your team up to speed quickly.
If you need help, you can always reach out to our customer support team — being able to quickly get actionable tips from our implementation experts is one of the things our customers value most.
“You could compare image files. You could compare massive Excel files. It’s much more useful than I thought it would be.”
See how New World Medical uses TVT to free up their team’s time instead of spending days on IFUs review
New World Medical uses TVT, TVT Artwork, and TVT Spelling to automate their content proofreading and prevent errors in documentation for devices available across 88 countries.
“If an error finds its way into labeling and documentation, it can lead to a product recall – and this is obviously something any company wishes to avoid. … [TVT]’s very effective.”
Senior Regulatory Affairs Specialist
