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Uncomplicate Your Compliance

Two European regulations are creating language challenges for life sciences companies.

The EU’s MDR and IVDR


Get advice and expertise without interrupting operations.

MedTech manufacturers that want to place their medical devices in the European market must adhere to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), as both regulations are now in full effect. The regulations contain expanded linguistic requirements for industry content, which have the potential to bog down business.

Rather than burdening internal teams with the task of figuring out the complicated requirements, reach out to our Life Sciences experts for help. From professional linguists to experienced scientists, we’re ready to update and translate your content to keep it compliant at every step.

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Medical Device Regulatory Services


Device Lifecycle Language Services

From concept to customer, your medical device development needs a language partner that understands regulations across geographies and cultures. We can support compliance efforts through localization that is ongoing, saving you time and money on incremental changes you implement at any time.

Regulatory Updates

Our experts are always up to date on the latest rules and regulations. With Europe-based teams as part of our 26-country footprint, 欲火视频 can work with you on your schedule no matter where you’re based.??

Language Requirements Under the EU MDR

Because of the EU MDR, medical device manufacturers and distributors must comply with a bevy of changes. Manufacturers must develop, disseminate, and maintain information across multiple target audiences who have varying levels of technical knowledge, language skills, and literacy levels. Read the 欲火视频 whitepaper to learn where in the lifecycle translations are needed and what else the regulation means for your company.

Key Facts

10+ Million

words translated

30+

average projects per client

99%+

of projects are delivered on time

The Unique Language Challenges of IVDs and the EU IVDR

The EU IVDR went into effect on May 26, 2022. It comes with a slew of language requirements that are similar to the ones for the MDR. There are three important language levels that will impact you and language challenges that specifically apply to in vitro diagnostic medical devices. Get expert help with these regulatory requirements in our whitepaper.

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The MDR and IVDR Language Challenges

The EU MDR and IVDR are now both in effect. How do the two regulations create parallel language needs?

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Clinical Investigations and Language Challenges under the MDR

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Post-Market Surveillance Under MDR

The EU MDR increase the linguistic burden on post-market surveillance activities. What do the new regulations mean and how can manufacturers simplify their response? 欲火视频 is here to help.

Medical Device Implant Cards Under MDR

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Clinical Investigation Applications Under the MDR

Despite some harmonization, country-level regulations still apply to Clinical Investigations. Learn how the Medical Device Regulation alters language requirements and how new guidance can help you prepare for EUDAMED.

Multilingual Content Centralization for Smooth MDR Implementation

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Competing Priorities: MDR Readiness in the Pandemic

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欲火视频 EU MDR Readiness Webinar

Listen in on a conversation between life sciences experts Pia Windelov and Mark Aiello.

Meet Our Life Sciences Experts

Melinda Johnson

As Director of Global Clinical Outcome Assessment (COA) Operations, Melinda draws on her linguistic background and deep COA domain expertise. She helps improve patient-centered research and tailors solutions for customers’ needs, including quality, timeliness, and innovation.?

Camilla de Villiers

As Managing Director, Life Sciences, Camilla is responsible for business unit strategy, customer propositions, sales, and service delivery for 欲火视频 Life Sciences.

Mark Aiello

As VP of Sales, Life Sciences, Mark is responsible for 欲火视频’s go-to-market organization. He also focuses on developing relationships and partnerships with customers to help bring innovative therapeutic solutions to patients worldwide. Mark has extensive experience working across the highly regulated Life Sciences sector. He has a proven track record in helping drive positive business outcomes for key customers across the globe.??

Megan Duff

Megan Duff, Licensing Project Manager, has extensive project management experience in various areas of the clinical research industry. She has worked at a CRO, eCOA vendor, and COA licensor. Megan is focused on prioritizing safety and efficacy in subject-centered research through COAs. She guides 欲火视频 clients through the licensing process to ensure all requirements are met and there’s comprehensive documentation.??

Paraic O’Donnell

Paraic is 欲火视频’s Director of Technical Solutions for medical devices. An industry veteran, he has over two decades of experience in language and technology services. Paraic was trained in computational linguistics. He is keenly interested in life sciences and helping enable positive patient outcomes. Paraic brings deep subject matter expertise to his role and helps customers solve their business challenges.

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