Medical Devices Localization

 

Interested in Medical devices localization? Read our articles below and learn best practices, tips and how-tos for a successful and effective localization strategy.

EU MDR translations

How Does the EU MDR
Affect the Translation Process?

The EU MDR is the European Union Medical Device Regulation 2017/745 that was released in 2017 by the European Parliament and the Council of the European Union and entered into application on 26 May 2021. The intent of the EU MDR regulation is to ensure a high standard of safety and quality for medical devices …

How Does the EU MDR
Affect the Translation Process?
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In-Country Review Challenges (1)

In-Country Review Challenges & How To Overcome Them

Listen to this article now:   The concept and processes of Quality Assurance in translation and localization have improved dramatically over the last decades. They have been further developed, refined and optimized by industry stakeholders on client and vendor side, and the process of refinement is still ongoing: translation software programs have emerged and are …

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Accuracy in Medical Translations (1)

The Importance of Accuracy in Medical Translations – The Case Of Willie Ramirez

Listen to this article now:   Grammatical errors and inaccurate translations can jeopardize any company’s image and reputation, but when it comes to the medical industry, where inaccuracy may have direct effect on patients’ lives, quality and accuracy are not just important, they are imperative. Medical translations ensure patients’ safety Medical translations are translations of …

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Commit ISO 13485 translations

ISO 13485 Translations for Medical Device Safety

Listen to this article now:   What is the ISO 13485 standard? ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is designed to be used by organizations involved in the design, production, …

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mHealth App Localization

mHealth App Localization: Do special regulatory terms apply?

Listen to this article now:   The rapid technological advances and the ever expanding use of mobile devices, from smartphones and tablets to wearables and wireless sensors, have not left the healthcare sector unaffected. In this article we will touch upon the definition of the mHealth apps, the relevant FDA policies and the EU regulations …

mHealth App Localization: Do special regulatory terms apply? Read More »

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