Accurate Specialist Translations for Regulated Content

Medical Technology

Translations for Medical Technology

Accurate. Consistent. Audit-Ready.
Translations in the medical technology sector are safety- and compliance-critical. They can directly affect user safety, regulatory conformity and market access.

COMLOGOS supports manufacturers and suppliers with specialist translations that combine linguistic precision, terminology consistency and audit-ready processes.

Why Medical Technology Translations Require Special Expertise

Medical technology content is subject to elevated quality and documentation requirements:

• Regulatory language requirements in each target market (EU MDR / international regimes)
• Direct impact on safe product usage
• Low margin for error in IFU, labeling and warnings
• Requirements for vendor and audit compliance
• Need for consistent terminology across product lifecycles

Errors or inconsistencies in translation can introduce regulatory risks, cause delays, and lead to misunderstandings.

Language Quality for Safety-Critical Content

In der Medizintechnik sind zahlreiche Inhalte unmittelbar sicherheitsrelevant.
In medical technology, many documents are safety-critical.
Translations influence how end users interpret instructions, warnings and regulatory content.

Even small linguistic inaccuracies can lead to misunderstandings, incorrect use, or audit findings.

That is why we maintain a strong focus on:

• clear terminology
• consistent specialist language
• accurate wording
• verification of critical elements (e.g., warnings, figures, units)

Our Services for Medical Technology & Digital Health

We support you with:

✔ IFUs / Instructions for Use
✔ Labeling / Packaging text
✔ Regulatory documentation
✔ Technical documentation
✔ Software UI / Help / eIFU
✔ Terminology management & glossaries
✔ Post-editing of machine translation

Quality & Process Assurance

All translation projects follow clearly defined processes certified against international standards:

• ISO 17100 — Translation process
• ISO 18587 — Post-editing of machine translation
• ISO 9001 — Quality management

Our quality assurance includes:

• Dual-review process (translation + revision)
• Documented QA checks
• Terminology and consistency control
• Verification of safety-critical elements (warnings, numbers, units)
• Version and change management

This ensures linguistically accurate results that hold up under regulatory scrutiny.

Guides & Resources

For deeper insight into language and quality requirements:

• Guide: Translations in the EU MDR environment
• Guide: Audit-ready translation process
• Guide: ISO 17100 quality framework

[Download PDF]

For Whom We Work

• Medical device manufacturers
• Component suppliers & OEM partners
• Digital health providers
• Software / SaMD companies
• Regulatory affairs, QA & technical documentation teams

Why Choose COMLOGOS?

• Expertise with regulated and technical content
• ISO-certified workflows
• Native-level specialist translators
• Structured QA and terminology assurance
• Reliable project coordination