5 Reasons Why ISO 13485:2016 Matters for Medical Device Content Translation

welocalize July 12, 2022

When it comes to medical device content translations, it’s critical to choose a language service provider (LSP) that adheres to strict international standards. 

The slightest translation error in instructions for use, product label, descriptions, and marketing materials can significantly compromise the product’s safety and performance. It can contribute to adverse events and risk patient/user safety and health. 

If you’re looking for medical content translation services, ensure they hold an ISO 13485:2016 certification. 

Did you know? the slightest translation errors in IFUs and product labels can comprise the safety of your #medicaldevice. Welocalize Life Sciences provides insight into 5 reasons why #ISO13485 matters for medical device content Click To Tweet


What is ISO 13485? 

ISO 13485 is a standard published by the International Standards Organization based in Switzerland.  It is intended to be used specifically by organizations involved in the design, production, installation and servicing of medical devices and related services. 

The standard defines the requirements for a quality management system (QMS), outlining obligations for manufacturers to monitor and control their internal processes and their outsourced processes that affect product’s safety and performance. 

Download our GuideISO 13485 is more refined with additional requirements for medical devices that aren’t listed in ISO 9001, such as:  

  • Documented purchasing procedure 
  • List of liable bodies for the QMS 
  • Clinical evaluation of products 
  • Requirements for medical device files 
  • Computerized systems validation 
  • Clear definitions of terms that apply to medical devices 

For more information about medical device translations and how ISO 13485 is factored in, download our guide: Best Practices for Localizing Medical Devices.  


Why Does an LSP Need a Medical Device Quality Standard? 

As per ISO 13485 requirements, when the translation process is outsourced, the manufacturer must be accountable for their LSP supplier. 

For these kinds of outsourced services, obtaining the certification is voluntary. Some LSPs only hold an ISO 9001:2015 certification and process additional requirements as needed within a Service Level Agreement. 

LSPs that translate medical device content, however, must hold an ISO 13485:2016 certification according to requirements set by many manufacturers and / or markets.  

Here are the top five benefits of choosing LSPs with an ISO 13485:2016 certification. 

1. Measures in Place to Create High-Quality Medical Translations 

If you choose an ISO-certified LSP, rest assured they implement strict measures to ensure the quality, accuracy, and consistency of medical translations. 

Adhering to an ISO standard, and not just ISO 13485, involves adopting their core principles in building a QMS. This includes the core principle of continuous improvement, which instills an ongoing pursuit of progress and success within an LSP’s culture. 

ISO 13485 also helps LSPs maximize the efficiency of their operations with outlined standards that minimize errors and wasteful practices in their QMS. This can be topped off by a professional development program that keeps the LSP’s medical translation team aligned with the standard. 

2. Translation Technologies Increase Efficiency 

Part of ISO 13485 is the requirement of adequate infrastructure “to achieve conformity to product requirements.” This encompasses the facilities, equipment, and support software needed to ensure quality and work efficiency. 

In other words, an ISO 13485:2016 certified LSP went beyond the traditional infrastructure needs of translation service providers. They invested in equipment and software specifically for handling medical device translations, like tools for glossary management and product information management. 

3. Strict Linguist Selection Criteria  

An ISO 13485:2016 certification proves that an LSP is committed to clients in the medical and healthcare industries. 

Translation companies won’t go through the trouble of obtaining an ISO 13485:2016 certification for just one client. Rather, they do it to cater to multiple medical and healthcare clients in the long run. 

That also means they have a full-time team of dedicated experts for medical, healthcare, and other life sciences translations, including subject matter experts and technical writers for content, such as:  

  • Instructions for Use 
  • Package inserts  
  • Technical manuals 
  • Data sheets 
  • Regulatory documents 
  • Intellectual property documents and patents 
4. Assurance of Ongoing Compliance Measures 

The certification body performs surveillance audits that ensure certified businesses continue to comply with the standards, even after earning their certification. This makes certain processes run smoother when bringing medical products into the international market. 

For example, in-country reviews (ICRs) ensure the compliance, effectiveness, and safety of medical device products pushed for global distribution. However, manufacturers usually appoint employees from the target country to conduct ICRs, regardless of their official positions. They can be product managers, salespeople, or clerical staff. 

Since ICRs are not their priority, the review process becomes unpredictable, and sometimes this leads to delayed or even canceled releases. LSPs certified according to ISO 13485 can issue a Certificate of Accuracy to avoid setbacks in the ICR process. It effectively replaces any sign-off form from reviewers, making it easier to stick to the product’s release timeline. 

5. Improved Decision-Making and Internal Processes  

ISO-certified LSPs are required to use evidence-based decision-making in every aspect of their service. This impacts not just the efficiency of their QMS, but also the organization’s leadership and improvement strategies. 

A fact-based approach is also important in ensuring effective internal processes and accurate communication of important documents related to a medical translation job. This includes the medical device’s proper use, safety guidelines, compliance documents, and any records from clinical trials. 


Work With Welocalize Life Sciences 

Consumer safety is paramount to organizations in the medical device industry. Welocalize holds ISO 9001:2015, ISO 17100:2015, ISO 13485:2016, and ISO 18587:2017 certifications to guarantee reliable quality and accuracy of translated materials. Fewer than 3% of language service providers have achieved this high standard. 

To learn more, visit our language translation and localization service page in medical device manufacturing and other highly regulated industries, or contact us here.