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Marek Makosiej
By
June 02, 2023
19 min read

What Do Medical Device Translation Companies Hide?

What Do Medical Device Translation Companies Hide?

 

 

 

Medical device translation companies ensure that medical devices are available worldwide to patients, healthcare providers, and manufacturers.

 

This blog article post will explore what language firms hide from their clients and what you need to know before choosing a medical device translation company.

 

We'll review the importance of providing accurate translations of user manuals for medical staff and patients, complying with local laws and regulations, and prioritizing patient safety. We'll also discuss the significance of translator expertise in healthcare and ISO certification for medical device translation.

 

Lastly, we'll provide tips on how to find the best medical device translation services and what questions to ask before signing a contract. Don't let hidden factors impact your medical device translations - read on to stay informed.

 

 

 

 

Medical Devices Worldwide - Short Overview

 

 

 

The global medical device market is expected to grow exponentially in the next few years, and medical device translation companies play a critical role in helping manufacturers expand into international markets.

 

 

 

The global medical device market is expected to grow exponentially in the next few years, and medical device translation companies play a critical role in helping manufacturers expand into international markets.

 

 

 

According to the latest predictions:

 

  • Revenue in the Medical Devices segment is projected to reach US$ 470.60bn in 2023.
  • The market's largest segment is Cardiology Devices, with a projected market volume of US$ 66.07bn in 2023.
  • Revenue is expected to show an annual growth rate (CAGR 2023-2027) of 5.59%, resulting in a market volume of US$ 585.00bn by 2027.
  • In global comparison, most revenue will be generated in the United States (US$ 163.70bn in 2023)

 

 

Ensuring accurate translations is vital due to the regulatory landscape varying widely across different countries, as any errors can have dire consequences, such as patient harm or harm to a company's reputation.

 

 

 

 

 

What Kind of Translation Services do You Need for Medical Equipment?

Choosing a reputable company with language and medical terminology expertise is crucial for medical equipment translation. This includes translating user manuals, software, and labelling. A quality control process ensures accuracy. Working with a professional translation company helps meet regulatory requirements and expands market reach.

 

 

 

Choosing a reputable company with language and medical terminology expertise is crucial for medical equipment translation. This includes translating user manuals, software, and labeling. A quality control process ensures accuracy.

 

 

 

With a team of professional translators, project managers, and subject matter experts, medical device translation services provide high-quality translation projects such as:

 

 

  • User manuals
  • Data sheets
  • Product manuals
  • Packaging and labeling
  • IFUs (Instructions for Use)
  • Clinical trials
  • Consent forms

 

 

 

Ensuring accurate translations is vital due to the regulatory landscape varying widely across different countries, as any errors can have dire consequences, such as patient harm or harm to a company's reputation.

 

 

 

  • Technical specifications
  • Software and mobile applications
  • Marketing materials for the healthcare industry
  • Device safety certifications
  • Legal documentation

 

 

 

 

Make Patient Safety Your Top Priority

Ensuring patient safety is paramount when it comes to translating medical devices. To achieve accuracy in the documentation and labeling of medical devices across international markets, companies require the services of a reputable medical translation company with expertise in the field.

 

Such a company should strictly comply with regulations while conveying critical safety information in clear language. Working with such professionals helps meet regulatory requirements and expand market reach while maintaining high-quality project management.

 

 

 

 

Comply With Local Laws and Regulations

Medical device translation can be complex to comply with local laws and regulations in the European Union, the United States, and any other markets you plan to expand globally. Medical translators must have subject matter expertise to understand regulatory requirements for labeling, IFUs, and marketing collateral.

 

Working with a medical device translation service provider with experience comprehending country-specific regulations is critical. Such providers typically have established quality management systems and a team of certified medical device translators to provide high-quality medical device content translations, including user guides, training materials, data sheets, product manuals, packaging, etc.

 

 

 

 

Provide User Manuals for Medical Staff and Patients

Without proper translation of user manuals and instructions, medical device staff and patients may not understand how to operate the machine or administer treatment properly. This can lead to severe consequences such as incorrect diagnosis, injury, or even death.

 

A reliable medical device translation company ensures that all user manuals are accurately translated into the target language. The translations consider the target audience's different cultural nuances and idiomatic expressions. Medical device companies can ensure patient safety by providing clear user manuals to medical staff and patients while reducing legal liabilities.

 

 

 

 

Maintain Confidentiality to Protect Sensitive Information

Professional medical device translation services prioritize confidentiality to safeguard patient information. Linguists experienced in medical translation work under strict agreements to protect sensitive data according to international standards like ISO 13485 and EU MDR.

 

Language companies have access to encryption technologies and secure file-sharing platforms to ensure that all data remains confidential throughout translation. This is especially important when dealing with patient data, which must always be protected.

 

Manufacturers can protect sensitive information by partnering with a reputable medical device translation company while communicating effectively with their global audience.

 

 

 

 

 

 

Medical Device Translation Services: are There Any Skeletons in the Closet?

 

 

 

When expanding your medical device company globally, choosing a reliable service provider that can provide accurate translations of technical documentation such as user manuals, labeling, and clinical research data sheets in the target language is essential while maintaining consistency and precision.

 

 

 

A team of professional translators with subject matter expertise in healthcare and terminology management can ensure the highest quality medical translations that comply with regulatory requirements

 

 

 

Confidently partner with a medical device translation company knowing that secure agreements maintain your patient information.

 

 

 

 

Ensuring Accuracy in Medical Device Labeling and User Manuals

Focusing on accuracy and precision in medical device labeling and user manuals is crucial to ensuring the safety of patients. Professional translators with subject matter expertise and a team of linguists can guarantee technical accuracy by implementing quality management systems (QMS).

 

Along with proofreading and editing, terminology management is critical to maintaining consistency across translations. Medical device translation services can deliver the highest quality results by following regulatory requirements and adhering to confidentiality agreements.

 

 

 

 

Importance of Translator's Expertise in Healthcare

Translators with specialized knowledge in medicine and linguistics are vital for precise translations of complex medical device content. Medical device translation services should employ subject matter experts who possess a deep understanding of regulatory compliance and terminology management for the highest quality and precision.

 

An inexperienced freelancer can compromise the accuracy and quality of your medical device translations.

 

Ensure you partner with a reliable medical device translation company that guarantees subject matter expertise, linguistic proficiency, and regulatory compliance for all translations. With their industry knowledge and experience, they can provide accurate translations that meet global standards and regulations, allowing you to expand your business into new markets confidently.

 

 

 

 

ISO Standards and Certification

ISO certification is critical for ensuring translation accuracy and consistency. This certification guarantees adherence to industry standards like regulatory compliance, terminology management, and technical accuracy while handling confidential information.

 

Expertise in medical and linguistic fields, quality management systems, and certified translators with relevant experience are essential for high-quality translation projects for medical device manufacturers. Localization of clinical trials, product manuals, labeling, documentation, marketing collateral, user guides, IFUs, or installation manuals requires precision without compromising patient safety or user experience.

 

 

 

 


 

 

 

Related content: What Happens When You Experiment with Machine Translation

 

 

 


 

 

 

 

Machine vs. Human Translation for Medical Devices

For medical device translation projects, accuracy is paramount for regulatory compliance and patient safety. Combining machine and human translation ensures the highest quality while still keeping costs manageable.

 

Machine translation helps increase efficiency and speed in the translation process by using advanced algorithms to translate large volumes of text quickly. However, it may not capture nuances and contextual meanings accurately compared to human translation.

 

 

 

For medical device translation projects, accuracy is paramount for regulatory compliance and patient safety. Combining machine and human translation ensures the highest quality while still keeping costs manageable.

 

 

 

On the other hand, human translation provides subject matter expertise and cultural awareness, ensuring that translations are accurate and culturally appropriate. Combining both approaches ensures the best of both worlds and guarantees high-quality translations that meet global regulations.

 

Partnering with a professional medical device translation company ensures that your translations will be completed efficiently, accurately, and within budget. By doing so, you can expand your business into new markets while

 

 

 

 

Localizing Medical Device Software

Adapting medical device software to meet the specific language and cultural needs of a target market is crucial. Expert knowledge of both language and technical aspects is required for successful localization.

 

A professional medical device translation company understands the technical complexities of software localization and has subject matter experts in both language and technology. They can leverage industry-specific tools to ensure a seamless transition from the source language to the target language.

 

 

 

Localization involves translating texts and adapting graphics, symbols, units of measurement, and cultural preferences to ensure that the final product is user-friendly and culturally appropriate.

 

 

 

Localization involves translating texts and adapting graphics, symbols, units of measurement, and cultural preferences to ensure that the final product is user-friendly and culturally appropriate.

 

Partnering with a reliable medical device translation company ensures your software is localized accurately, compliant with regulations, and meets user expectations. By providing your users with tailored software experiences, you enhance patient safety and satisfaction while using the equipment daily.

 

 

 

 

Compliance and Liability in Case of Emergency: Localization Errors

Ensuring compliance with local regulations is crucial for any reputable medical device translation company. Compliance and liability issues must be addressed when translating medical devices for use in different markets.

 

Localization errors can have severe consequences for patient safety and product efficacy. Implementing quality assurance processes such as proofreading and editing is essential for any translation project to ensure accuracy in medical translations.

 

 

 

Errors and omissions insurance is another essential aspect to consider when partnering with a medical device translation company. This type of insurance protects against potential legal actions resulting from errors or omissions in the translation process.

 

 

 

Errors and omissions insurance is another essential aspect when partnering with a medical device translation company. This type of insurance protects against potential legal actions resulting from errors or omissions in the translation process.

 

A reliable medical device translation company will also have contingency plans in place for emergencies such as product recalls, ensuring that they are equipped to handle any issues that may arise.

 

 

 

 


 

 

 

Related content: 7 Tips to Avoid Wasting Your Translation Budget

 

 

 


 

 

 

 

How to Find the Best Medical Device Translation Companies?

 

 

 

When searching for medical device translation services, prioritize companies with experience in the field and native speakers of the target language. Quality assurance processes are crucial for accuracy and consistency, so verify their existence. While cost is essential, don't sacrifice quality for a lower price.

 

 

 

When searching for medical device translation services, prioritize companies with experience in the field and native speakers of the target language.

 

 

 

 

 

Essential Questions to Ask Before Signing the Contract

When looking for a medical device translation services provider, asking the right questions before signing a contract is essential.

 

Start by ensuring that the company has experience in medical device translation and employs certified translators who specialize in your target language. Research its reputation and look for reviews from satisfied customers.

 

In the video below, you can find seven key questions to ask before buying localization services. Be sure to watch it and save the Qs for your next partner research.

 

 

 

 

 

 

 

 

Ensure your new language partner has a quality management system (QMS) to guarantee translations' precision and technical accuracy. Finally, check if they have expertise in localizing documentation such as user manuals, IFUs, clinical trials, and software localization.

 

Remember to ask about regulatory compliance - especially if your product is bound for the EU market- and the data security measures they use when handling confidential patient information.

 

 

 

 

Be Aware of Extra Services and Charges

Remember that when selecting medical device translation services: it is essential to be aware of the additional services and charges included in the process. Always opt for a company with experience in medical device translations, certified translators, and quality assurance processes.

 

Language companies can charge extra for:

 

  • Machine translation post-editing
  • Document formatting
  • Translation memory files upkeep
  • Desktop publishing
  • Project management
  • Quality assurance testing

 

While choosing a provider with the lowest price may be tempting, sacrificing quality for a lower price will ultimately cost you more in the long run.

 

Ensure the company is transparent about its pricing and service offerings before signing a contract. This way, you can avoid any surprises. Ask for a free quote before committing to any test translation projects.

 

Turnaround time, cost, and customer support should all be considered before deciding. To ensure accurate translation within regulatory compliance, terminology management is critical, along with expert linguistic validation.

 

 

 

 


 

 

 

Related content: 7 Things Your Translation Project Manager Handles for You So You Don’t Have To

 

 

 


 

 

 

 

What is the Minimum Fee for Translation?

What is the minimum fee? It's the lowest amount a translation company will charge for their services, regardless of the project size. It's important to keep in mind that this fee may not include additional services or charges, such as those mentioned above. Remember that the minimum fee may vary depending on the scope and complexity of the project.

 

When comparing quotes from different companies, make sure you are comparing apples to apples. Look at what is included in the price and what is not. Remember that a higher price may reflect better quality and more comprehensive services.

 

 

 

 

 

 

 

 

Ultimately, investing in a reputable and experienced medical device translation company will ensure accurate translations that comply with regulatory requirements and avoid costly mistakes down the road.

 

 

 

 

Liability Insurance in Case of Errors and Omissions

Protecting your business from financial loss due to errors or omissions during medical device translation is critical. Liability insurance coverage should be one of your top considerations when selecting a medical device translation services provider.

 

Otherwise, you may be held responsible for any mistakes made during the translation process, which can result in costly legal and financial issues.

 

Inquire about the type and amount of liability insurance a translation company carries. It's also important to understand what kind of errors and omissions are covered under their policy. This will give you peace of mind and protect your business from unforeseen circumstances.

 

 

 

Choosing a medical device translation company offering liability insurance coverage is essential to safeguarding your business and ensuring successful international market entry.

 

 

 

Choosing a medical device translation company offering liability insurance coverage is essential to safeguarding your business and ensuring successful international market entry.

 

To ensure the highest quality results for your documentation needs, partner with a reputable language firm with certified translators and extensive expertise in the field. Remember to check reviews and references from prior clients and ensure compliance with relevant regulations.

 

 

 

 

Machine Translation Impact on the Overall Cost

Regarding medical device translation companies, it's important to remember that machine translation can accurately impact the overall cost of translating medical device content. Large volumes of content can be translated quickly and at a lower cost using machine translation.

 

However, it's important to note that machine translation quality may not always be up to par with human translation. Although it can be helpful in some instances, using machine translation for highly technical documentation, such as product manuals or installation manuals, can lead to inconsistencies in terminology and technical accuracy.

 

 

 

Although it can be helpful in some instances, using machine translation for highly technical documentation, such as product manuals or installation manuals, can lead to inconsistencies in terminology and technical accuracy.

 

 

 

When considering machine translation for medical device content, it's crucial to have a post-editing process where a trained linguist reviews and edits the machine-translated text. This ensures that accurate and reliable translations are produced.

 

Ultimately, the decision to use machine or human translation comes down to the specific needs of your medical device documentation project. An experienced medical device translation company can work with volumes of content and offer you a combination of both machine and human work to give you the best possible price.

 

Working with professional translators with subject matter expertise is essential for ensuring precision in translation and consistency throughout all documentation. By partnering with a team of experts specializing in medical device translation services, you can ensure compliance with regulatory requirements while avoiding costly errors.

 

 

 

 


 

 

 

Related content: A Guide to Understanding Translation and Localization Terminology

 

 

 


 



 

 

This is What Translation Companies Don't Tell You

When choosing a medical device translation company, be aware that some may need to be more transparent about pricing, outsourcing practices, or quality control measures. To ensure a successful partnership, ask questions and conduct thorough research to find a trustworthy provider.

 

 

 

 

 

 

 

 

You can save the tips from the video for your partner's research and ask to get in-depth answers. It's better to be safe than sorry, right?

 

 

 

 

 

 

Take Your Medicine

 

 

 

Selecting the right medical device translation company is crucial to ensure your products' safety, efficacy, and compliance. Beyond just language skills, you must consider factors such as expertise in healthcare, adherence to regulations, confidentiality measures, and liability insurance.

 

 

 

Ask the right questions and understand all aspects of the translation process before signing a contract. Refrain from letting hidden fees or lack of liability insurance catch you off-guard.

 

 

 

Ask the right questions and understand all aspects of the translation process before signing a contract. Refrain from letting hidden fees or lack of liability insurance catch you off-guard. Read our recommended blog articles for more information on medical translation, or contact us today for personalized quotes.

 

 

 


 

 

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