Quality Assurance
Automated QA checks for error-free medical device translations
Comprehensive error detection
Over 30 automatic check rules cover all critical areas: from terminology consistency and number and unit verification to detection of missing mandatory regulatory statements in the translation.
Ensure regulatory compliance
Medical device-specific check rules ensure that all information, warnings, and symbol definitions required under MDR and IVDR are completely and correctly included in the translation.
Faster review process
Reviewers no longer need to deal with obvious errors. The automatic QA check filters out technical errors so that human review can focus on content and stylistic aspects.
How it works
Configure QA profile
Choose from predefined QA profiles for medical devices or create your own profile with custom check rules. Define which checks should be classified as errors and which as warnings.
Automatic real-time checking
During translation, manualworks checks each segment in real time against the active QA profile. Errors and warnings are displayed directly in the editor, allowing translators to correct issues immediately.
Generate QA report and approval
Before approval, manualworks generates a complete QA report for the entire document. Only when all critical checks have passed can the translation be forwarded for final approval.
Quality Assurance as an Integral Component
In the translation of Instructions for Use for medical devices, quality assurance is not an optional step — it is a regulatory necessity. The MDR requires that Instructions for Use contain correct, complete, and comprehensible information. A missing warning, an incorrectly translated dosage specification, or inconsistent terminology can attract the attention of Notified Bodies during audits and, in the worst case, endanger patient safety.
manualworks integrates quality assurance directly into the translation process. Instead of discovering errors only in the final review — when corrections are time-consuming and costly — the system detects problems during translation and enables immediate correction.
Multi-Level QA System
The quality assurance system in manualworks operates on multiple levels. The first level comprises linguistic checks: spelling, grammar, punctuation, double spaces, and inconsistent capitalization. The second level verifies technical accuracy: numbers, units, date formats, formatting, and segment completeness.
The third level, which is decisive for medical devices, addresses regulatory compliance. Here, manualworks checks whether all mandatory information according to MDR Annex I is present, whether warnings have been correctly and completely translated, and whether terminology matches the approved glossary. This level can be extended with product-specific checklists.
Real-Time Feedback for Translators
A key advantage of the integrated QA system is immediate feedback. Translators see errors and warnings directly next to the relevant segment — while they are still working. Color coding distinguishes between critical errors (red) that must be resolved before approval, and warnings (yellow) that recommend review.
This real-time feedback significantly shortens the entire translation cycle. Errors are corrected where they originate, rather than being discovered days or weeks later in the review process. This saves time, reduces costs, and increases satisfaction for all stakeholders.
Traceable QA Reports
For each translation assignment, manualworks generates a detailed QA report that documents all checks performed, errors detected, corrections made, and remaining warnings. This report is part of the audit trail and demonstrates to Notified Bodies and authorities that a systematic quality assurance process was carried out.
Frequently Asked Questions
What types of errors does the QA system detect automatically?+
The manualworks QA system checks for numerous error types: missing or deviating translation segments, inconsistent terminology usage, number and unit errors, missing or incorrect formatting (lists, tables, bold text), untranslated passages, double spaces, and punctuation errors. In addition, the system specifically checks for medical devices whether all mandatory warnings and regulatory statements are present.
Can custom QA rules be defined?+
Yes, in addition to the predefined standard checks, you can create custom QA rules. For example, you can specify that certain phrases must always or never be used, that product names should not be translated, or that specific regulatory phrases must be adopted verbatim. These rules can be defined at company, product family, or project level.