Paspartu Multilingual Operations for Regulated Markets
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Medical DevicesDocumentation built for MDR compliance and market readiness

Medical device manufacturers operate under strict regulatory frameworks, complex documentation requirements, and constant change. Paspartu partners with MedTech teams to deliver compliant, accurate translations that meet MDR and IVDR requirements-while supporting product launches, updates, and audits across markets. From technical documentation to labeling and IFUs, we help you stay compliant and move forward with confidence.

Medical Devices
The Challenge
When documentation accuracy defines market access

Medical devices translations play a critical role in:

  • Regulatory approval
  • Patient and user safety
  • Market readiness
  • Audit and inspection outcomes

MedTech teams face challenges such as:

  • Meeting EU MDR and IVDR requirements across multiple languages
  • Managing complex documentation sets (IFUs, labels, technical files)
  • Maintaining terminology consistency across products and versions
  • Supporting frequent updates driven by design changes or regulatory findings
  • Ensuring documentation is audit-ready at any point in time

In this environment, documentation errors can delay launches, trigger findings, or block market access.

Our Approach
Compliant by design. Aligned to your operations.

Paspartu works as an extension of your regulatory, quality, and documentation teams-combining certified processes with a flexible, collaborative way of working.

We support Medical Technology companies through:

Regulatory-grade accuracy
Structured workflows, subject-matter expertise, and rigorous QA ensure translations aligned with MDR and IVDR expectations.

Launch and update readiness
We support initial submissions, product launches, and ongoing updates-adapting to your change control and release cycles.

Terminology and consistency control
Glossaries and translation memories ensure consistent use of approved terminology across documentation and markets.

Format and layout integrity
We preserve structure, references, and layouts across complex formats, including IFUs, manuals, and packaging content.

Partnership mindset
We adapt to your tools, teams, and processes-taking ownership of outcomes, not just deliverables.

What We Support
Medical device documentation we handle every day
  • Instructions for Use (IFUs)
  • Labeling and packaging content
  • Technical documentation and files
  • Quality and compliance documentation
  • User manuals and training materials
  • Regulatory submissions and updates

All delivered with a focus on compliance, clarity, and operational reliability.

Why Medical Devices Teams Choose Paspartu
Trusted where documentation must withstand scrutiny

Our MedTech partners value Paspartu for:

  • Proven experience in regulated, safety-critical environments
  • Certified processes supporting MDR and IVDR documentation requirements
  • The ability to scale across products, languages, and markets
  • A responsive, collaborative approach that fits real-world operations

The teams we support trust us because our work consistently meets the standards they are accountable for.

Support your next submission, launch, or audit with confidence

Whether you are preparing MDR documentation, launching a new device, or managing ongoing updates, we are ready to support you.

Talk to a MedTech localization specialist

or you can call us at: +30 210 95 71 777

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Paspartu Multilingual Operations for Regulated Markets
Let’s talk