Engage Customers Globally with the Best IVD Translation Services
Stepes (pronounced /’steps/) provides ISO 13485 certified in-vitro diagnostic device translation services with speed in all European, Asian, Latin American, and most African languages. Our IVD translation solutions help medical device companies achieve global success with the best multilingual communications and international regulatory compliance.
Accurate IVD Translations You Can Trust
Are you manufacturing in-vitro diagnostic medical devices and need to translate product documentation, IFUs (information for use), regulatory submissions, or clinical outcome assessments between English and Spanish, English and Portuguese, English and German, as well as many other languages? Then look no further than Stepes. We provide comprehensive IVD translation services that deliver linguistic accuracy and fast turnaround so IVD companies can get ahead faster in international markets. Stepes has a large team of professional life sciences translators and subject matter experts who utilize our industry-leading translation memory and terminology management solutions on the cloud to translate IVD content with confidence at speed and scale.
Consistent and accurate IVD medical device translations require linguistic experience, subject matter expertise, localization best practices, and modern AI-powered translation technologies that leverage the power of machine-human capabilities. Stepes’ cloud translation management system automates many of the non-essential manual touch points within the traditional localization workflows such as document analysis, quotation creation, linguist assignment, project tracking, linguistic review, and invoice/billing. The result is a highly efficient IVD translation process that delivers linguistic consistency, technical accuracy, and localization efficiency without breaking the bank. We help the world’s leading in vitro diagnostic medical device companies achieve international success, one accurately translated IVD document at a time.
Quality IVD Translation for Regulatory Compliance
The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have stringent documentation requirements concerning patient safety. These EU laws make translation of the technical content mandatory for medical device manufactures to market IDV devises in any of 24 EU countries. The U.S. FDA and regulatory authorities in Japan and China have implemented similar regulation requirements for medical device manufacturers to produce accurate IVD medical device documentation in the respective local languages. Stepes is an ISO 9001:2015 and ISO 13485:2016 certified translation company and we provide professional IDV translation services in All European and Asian languages that allow clients to achieve MDR, IVDR, and MDSAP as well as global regulatory compliance. We offer a full suite of language translation solutions that IVD companies need to ensure the highest level of localization quality, including linguistic validation, back translation, language reconciliation, medical device terminology management, and multilingual clinical trial translations.
Medical Device Labeling Symbols
In Vitro Diagnostic Device Labeling Translation
The U.S. FDA and other international regulatory authorities require clear labeling of IVD devices to ensure proper use and patient safety. A typical IVD label should include the established (proprietary) product name, intended use, warning statement for hazardous substances listed in 16 CFR part 1500, and a clear marking “For In Vitro Diagnostic Use”, etc. When the IVD device is marketed globally, product labels must be accurately translated into the target country’s official languages to ensure regulatory compliance. This is where Stepes can help. We provide IVD companies with linguistically fluent and technical accurate translation services for product labels that deliver the best quality and speed in Chinese, Spanish, Portuguese, and 100 other languages.
For IVD products that come in the form of reagents, the labels must contain information on quantity and concentration of all active ingredients (weight per unit volume.) For reagents manufactured from biological ingredients, the label must include the source and measure of its activity (bovine, I.U., etc.) IVD labels for reagents also include storage instructions such as temperature and humidity, as well as information on mixing or reconstitution, product purity, expiration date, and visual inspection descriptions. Stepes has experience translating both technical information as well as numbers, dates, unit conversions and formats. In addition to language translation, Stepes also has a large team of professional desktop publishers who’re specially trained to format the translated IVD labels in all languages including bi-direction languages such as Arabic and Hebrew so the localized labels look professional.
Point of Care IVD Translation
The global POC (Point of Care) diagnostic device market has been rapidly growing, driven by healthcare moving towards telehealth to improve patient convenience and increase accessibility of care. Point of Care IVD medical devices allow testing to occur remotely at the site of patient care such as private homes, enabling physicians to receive test results remotely in real time that drives better-informed and more efficient treatment decision making process. Social distancing mandated by the Coronavirus pandemic only serves to accelerate the growth of POC IVD market as more medical device companies introduce portable and handheld devices and test kits to perform a variety of self-administered diagnostic functions remotely. This is why you need Stepes. We help medical device companies translate technical documents, on-device software, safety warnings, as well as training and elearning videos for a variety of point-of-care IVD devices. Better yet, we use translation memory so translated content can be leveraged for future projects, achieving cost savings and fast turnaround at the same time.
Comprehensive Medical Device Translation Solutions
Stepes is a leader in enterprise medical device translation services at speed and scale. We’ve redefined professional medical device localization to an agile, on-demand, continuous, and 24/7 online model. Our AI-powered, cloud-based translation management system has streamlined and automated the entire medical translation lifecycle to deliver unrivaled localization performance and ROI. Stepes provides comprehensive translation solutions covering all areas of the medical device manufacturing supply chain, including document translation, software localization, elearning translation, remote interpretation, technology patent translation, and global regulatory compliance consulting. To learn more, please visit Stepes Medical Device Translation Services.