Medical Device Translations
When lives are at stake, trust the experts.
Medical device translations have always been critically important – after all, patients everywhere need to be able to identify and properly use a product no matter what language they speak. However, new regulations such as the EU MDR and IVDR that put the responsibility for translation on the manufacturers rather than the EU member states have made the potential consequences of poor-quality translation and localization even more serious. Before any medical device can be approved for sale, it has to pass strict registration procedures and abide by newly drafted regulations. All instructions and specifications need to meet strict language and translation criteria, and rebranding to account for cultural differences is also a must.
A focus on quality
Trusting your medical device translations to Argos Multilingual means trusting them to a dedicated and experienced team of translators, linguists, quality assurance specialists, and localization engineers. We are one of a few specialist medical device translation companies capable of accurately adapting all medical device content to comply with international, regional, and local laws. We follow strict ISO quality processes, and we have introduced our own medical quality assurance measures that are based on LQA and J2450 compliance and designed specifically to meet strict international regulation measures related to medical device translation and language services. In addition, our standardized processes can improve your content’s consistency across multiple languages.
We specialize in the translation and localization of all types of content, including (but not limited to):
- Medical devices and equipment
- Anesthesia delivery
- Patient monitoring
- Sterilization/infection control
- Radiology/ultrasound imaging
- Surgical instruments
Timeliness and accuracy are crucial factors in choosing a translation partner no matter what your industry, but they’re especially important where clinical trials are concerned – the ability to meet registration requirements hinges on translation quality and content accuracy. That’s why market-leading clinical research companies and pharmaceutical manufacturers have come to depend on Argos Multilingual and our guarantee of quality.
Our confidence in that guarantee comes from our practice of combining multiple quality metrics into a single quality management system (QMS) that measures all quality assurance processes, storing the results for future reference and providing us with data for feedback and quality control. Our quality assurance managers can examine areas that need improvement while the system shows the results of past changes, and we’ve also incorporated Six Sigma principles that analyze and categorize errors to determine both their standard deviation and any corrective actions that need to be taken. This means that we can easily design unique workflows that enable us to deliver mistake-free translations for all your projects.
When you work with us, you can be sure that your project will be overseen by a seasoned project manager with extensive experience in related disciplines. Every translator and editor we partner with is a formally educated native speaker with a background in medicine and biotechnology, and the technical accuracy and consistency of our linguistic experts is complemented by our use of new language technologies like translation memories and terminology glossary management systems. What’s more, our extensive experience in life sciences gives us comprehensive translation source content, which allows us to substantially reduce translation costs and pass the savings on to you.
In the eyes of regulatory agencies, hiring an ISO-certified language service provider is the same as having an in-house translation and localization department with approved processes that are ready to be audited at any time. There’s a very real difference between providers who are properly certified and those who only present themselves as ISO “compliant”, and we’re proud to be one of a small number of language service providers that are already certified to the ISO 13845:2016 standard.
Our quality processes are the result of years of partnering with some of the world’s largest medical device and pharmaceutical manufacturers. We offer professional clinical trial translation services aimed at making sure that the content delivered for your clinical trials is in line with government regulations and uniform across all languages. That applies to all your clinical trial content, including patient information sheets, informed consent forms, patient diaries, and other medical records.
Confidentiality at Argos Multilingual
Everyone we employ is made aware that the information and data they have access to is confidential through comprehensive employee onboarding training provided by our IT department. We are certified and compliant with the ISO 27001 standard, the GDPR, and the Polish Protection of Personal Data Act, and we submit to periodic information security and cyber-security risk assessments performed by an ISO specialist. Thanks in part to this, we’ve never had an incident or a breach of privacy or security. In addition, all our data is classified and secured according to its level of risk, and we have procedures for the notification and escalation of security incidents.
Want to know more?
- Have a look at our Whitepaper on the new EU Medical Device Regulations!