Life sciences translation experts

Medical Device Translation Services

Conversis is a leading provider of medical device translation services to organizations across the globe. Unlike generalist translation agencies, who dilute their focus across multiple industries, we have spent over 20 years learning all there is to know about just one – life sciences.

As life sciences translation experts, we can support you across the entire medical device lifecycle, from pre-market research, through submission, to post-market surveillance. Our in-house team includes experienced project managers, process experts, and technology specialists, while our worldwide network of 3,000+ linguists is made up entirely of native speakers, qualified in life sciences.

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The Medical Device Translation Lifecycle.

Preclinical: Research, Development & Validation

Technical & market research
Technical documentation (TDs)
Risk assessments (ISO 14971)
Design validation & verification reports
Design history files (DHF)
Usability evaluation
Clinical evaluation reports (CERs)

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Clinical Investigations & Trials

Clinical trial protocols
Patient recruitment materials
Informed consent forms (ICFs)
Patient information leaflets (PILs)
Investigator brochures (IBs)
eCOA/ePRO
Regulatory documentation
Lay summaries

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Regulatory Submissions & Compliance

Instructions for use (IFUs)
Unique device identification (UDI) labeling
Regulatory submissions (FDA 510(k), MDR Applications)
Packaging & labeling
Clinical evaluation reports (CERs)

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Post-Market Surveillance & Compliance

Logistics & distribution
Post-market surveillance (PMS) reports
Vigilance reports & adverse event reports (AERs)
Complaint handling reports
Device labeling updates
Post-market clinical follow-up studies (PMCFs)

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Corporate Communications

Product marketing & sales materials
Product support
Internal training materials
Investor reports
Standard operating procedures (SOPs)
Legal materials (contracts, compliance, policies)
HR material (onboarding, codes of conduct)

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Medical Devices

Our Medical Device Translation Expertise.

Conversis has been working with medical device companies and on medical device projects since 2003. So, we’re very familiar with the challenges, opportunities, and requirements of this industry. We understand that our clients need us at pivotal points in each phase of the product lifecycle.

We’ve seen the value of comprehensive market research to answer questions around feasibility and intellectual property. We are only too aware of the complexity and inconsistency of international regulations such as the MDR and IVDR. And we recognize the paramount importance of quality and patient safety above all else.

That’s why we have sector-specialist linguists living in their respective countries. It’s why we keep on top of changes to local and international regulations. And why we are ISO-certified for quality, security, and translation best practice.

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Medical Device Documents We Can Translate

Technical documentation (TDs)
Risk assessments (ISO 14971)
Design validation & verification reports
Design history files (DHF)
Usability evaluations
Clinical evaluation reports (CERs)
Clinical trial protocols
Patient recruitment materials
Informed consent forms (ICFs)
Patient information leaflets (PILs)
Investigator brochures (IBs)
eCOA/ePRO
Regulatory submissions (e.g., FDA 510(k), MDR Applications)
Lay summaries
Instructions for use (IFUs)
Unique device identification (UDI) labeling
Device master files (DMF)
Post-market surveillance (PMS) reports
Vigilance reports & adverse event reports (AERs)
Complaint handling reports
Device labeling updates
Post-market clinical follow-up studies (PMCFs)

…and more!

Why Work With Conversis.

Specialists in life sciences

In the sector since 2003

All processes created for life sciences

3,000+ linguists

330+ language combinations

People on the ground in 110 countries

All linguists have subject-matter expertise

ISO 9001, 17100 & 27001 – for quality, best practice & security

Experience in 50+ therapeutic areas

Coverage of full medical device lifecycle

AI tools developed for medical device requirements

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Translation Process

Our Medical Device Translation Process.

We value long-term partnerships, which is why each of our clients is assigned a dedicated project team. This team takes the time to develop a deep understanding of your unique needs so they can offer customized solutions.

When you have a project to launch, your project team will analyze your brief and put together an approach, costs, and a timeline. Depending on the project, we could propose an AI-assisted process or a strictly human one. In either case, the content will be finalized by our expert linguists.

Our in-house system allows us to search through our entire linguist network to find the perfect match for your project, checking against categories like domain expertise, language combination, and countries of origin and residence.

Our standard workflow for medical device projects can include some or all of the below phases:

Translation by linguist 1

Review by linguist 2

Second review by linguist 3, as required

Quality assurance by internal QA team

Client review

DTP & layout

In-situ review

Provision of ISO certificates

For a sample AI-assisted workflow, please visit our Solutions page.

Solutions

Trusted by organizations all over the world

What our clients say about working with us.

“Conversis is a great partner to work with. They are extremely responsive and accommodating from start to finish. They provide a high-quality service and enable us to hit deadlines for important clients. We consider them one of our trusted partners, and they have never let us down.”

Project Manager at Langland

“The team was always approachable throughout the entire project and worked effectively so that we were able to meet our tight deadline. The linguist’s understanding of the biology and technical aspects of the project resulted in the production of a highly competent translated document. We can therefore only recommend their work.”

Silke Fuchs, Regulatory Scientist at Target Malaria

“Working with the Conversis team has been a very positive experience. They are flexible, proactive, attentive to our needs, consistently respectful of deadlines, and dedicated to delivering the best possible outcome”

Survey Project Manager at EURORDIS

Case Studies.

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Medical Device Translation Services in Over 330 Language Combinations.

Our extensive network of linguists spans the globe, with experts residing in their respective countries, covering all regions worldwide. They allow us to offer translation services in over 330 language combinations, matching linguists to projects based on their subject area expertise. Each linguist is vetted and their experience verified before onboarding, and they are continually assessed throughout their relationship with Conversis.

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Medical Device Translation FAQs.

How much do your medical device translation services cost?

We evaluate each new project and create a quote for your approval. Costs vary based on factors like language combinations, service level, and content type.

If you would like to get an idea of costs for a project, please get in touch, providing any details you currently have, and we will produce a no-obligation quote for you.

How long does it take to have my material translated?

The timeline for a given project depends on volumes, complexity, and service level. Our standard turnaround for human translation is 2,000 words per day, and 1,000 words per hour for review. But we know what timelines can be like in the medical device world, especially when it comes to submissions, so if you have a specific deadline to work towards, we can usually make it happen. Just make sure to let us know as early as possible.

What qualifications/certifications/accreditations do you have?

At Conversis, our quality management system underpins everything we do. We are ISO 9001, 17100 & 27001 certified – the international standards for quality, translation services, and information security. These accreditations are evidence of our commitment to delivering secure, high-quality translations and implementing consistent, rigorous quality processes

How do you ensure the accuracy of your medical device translations?

Unlike generalist agencies, who work with generalist linguists, at Conversis, we only work with linguists who have specific life sciences expertise. We also follow a minimum one-step review process. This means that, following translation, all content is reviewed by a second linguist with the same qualifications. Where AI workflows are implemented, this is managed by sector experts and content is reviewed by our linguists.

In addition to the review process, our internal QA team conducts further quality checks to validate accuracy, consistency, and adherence to client specifications. We also use translation memory and termbases to ensure consistency of language within and across projects.

Are your medical device translations certified?

We can provide certificates for any medical device project we work on in our capacity as an ISO-certified translation partner.