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Medical Device Localisation: Enhancing Efficiency & Compliance

Posted 06 February 2024

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Medical device localisation is essential to meeting a target market’s linguistic, cultural and regulatory requirements.

  • Struggling to navigate the complex regulatory landscape of international medical device markets?
  • Worried about the accuracy and effectiveness of your translated user manuals and labelling?
  • Facing delays and setbacks due to inefficient localisation processes?

This article will break down how medical device localisation can enable you to break into new markets with confidence and accelerate speed-to-market. It’s a no-brainer for MedTech companies to have a trusted localisation partner in their corner as they prepare to launch in new markets across the globe.


Table of Contents

What Is Medical Device Localisation?

Medical device localisation refers to the process of adapting and translating medical device content, documentation and software to meet the linguistic and cultural needs of specific target markets. This crucial step ensures that healthcare products are accessible and compliant with regulatory requirements in diverse regions around the globe. Localisation is a vital part of successfully breaking into new markets.

Automated Localisation Workflows: Why Do They Matter?

The importance of efficient localisation workflows cannot be overstated. Automated localisation not only accelerates the time-to-market for medical devices but also ensures that they comply with regulatory standards in various jurisdictions.

What Are the Challenges in Medtech Localisation?

Inefficiencies Faced by MedTech Companies

Manual localisation processes often result in inefficiencies that hinder the growth and global expansion of MedTech companies. These inefficiencies include delays, errors in translation, and increased costs associated with human intervention in the localisation process.

Regulatory Affairs & their Cross-Functional Role

Regulatory affairs play a pivotal role in MedTech localisation by ensuring that products meet the regulatory requirements of each target market. However, the cross-functional nature of regulatory affairs can lead to administrative bottlenecks and potential compliance risks.

How Automation Accelerates the MedTech Localisation Process

Machine Translation in MedTech Localisation

Machine translation is a key component of automated localisation workflows. Advanced algorithms can translate medical content to a reasonable level of accuracy – which ensures linguistic precision while minimising the need for extensive human involvement during post-editing.

End-to-End Automated Processing Routines

From content extraction to translation and integration, end-to-end automated processing routines streamline the entire localisation workflow. This approach ensures consistency, accuracy and adherence to regulatory requirements throughout the process.

Regulatory Affairs in MedTech

Administrative Tasks & Inefficiencies

Regulatory affairs professionals often face administrative burdens associated with manual processes in MedTech localisation. Automation can alleviate these tasks, allowing regulatory teams to concentrate on strategic initiatives and compliance.

Compliance Risks Due to Manual Process Errors

Manual errors in the localisation process can lead to compliance risks, potentially resulting in regulatory setbacks and financial implications. Automation helps mitigate these risks by ensuring accuracy and consistency in regulatory documentation.

Lack Of a Single Source Of Truth

Manual processes may result in the absence of a single source of truth for regulatory information. Automated localisation workflows create a centralised and reliable repository. This can facilitate better regulatory oversight and management.

Enabling Innovation & Speed-to-Market

Regulatory affairs, when aligned with automated localisation processes, are an important part of fostering innovation within the MedTech industry. Streamlined regulatory workflows enable faster development cycles and quicker adoption of cutting-edge technologies. When MedTech companies address inefficiencies through automation, they achieve speedier market entry. Rapid regulatory approvals and compliance with local requirements contribute to the accelerated launch of medical devices globally.

Partnering With ALM Translations for Medical Device Localisation

To radically simplify MedTech localisation, companies can benefit from partnering with specialised linguists like ALM Translations. With expertise in automated localisation workflows, ALM Translations offers comprehensive solutions to ensure efficient, accurate and compliant adaptation of medical devices for global markets. Request a free quote from ALM Translations today.

Medical Translations

With both ISO 17100 and ISAE 3000-part II accreditation, ALM Translations is a medical translation specialist trusted by healthcare suppliers worldwide.

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Life Science Translations

With specialised workflows specifically designed for the life sciences sector, ALM’s life science translation service is trusted by some of the world’s largest organisations.

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