The world does not speak one language, hence it becomes necessary to make sure every personnel, irrespective of their linguistic capabilities are able to interpret and make the right use of any healthcare product or information. The Medical Device Regulations (EU) have shown significant importance towards Translations. The EU MDR now mandates every manufacturer to provide publicly accessible information in the local member state language. This is mandated in order to ensure efficient understanding and use of the medical device by all individuals.
OMC Medical Limited can assist you with your Translation needs. We are an ISO 17100:2015 certified translation service provider and have assisted several healthcare clients with their medical translations.
The world does not speak one language, hence it becomes necessary to make sure every personnel, irrespective of their linguistic capabilities are able to interpret and make the right use of any healthcare product or information. The Medical Device Regulations (EU) have shown significant importance towards Translations. The EU MDR now mandates every manufacturer to provide publicly accessible information in the local member state language. This is mandated in order to ensure efficient understanding and use of the medical device by all individuals.
OMC Medical Limited can assist you with your Translation needs. We are an ISO 17100:2015 certified translation service provider and have assisted several healthcare clients with their medical translations.
In case of e-IFUs, current versions in the applicable local languages should be readily accessible by the end user on the manufacturer’s website or any preferred public sharing platform.
We specialize in translating a wide array of medical documents, including user manuals , and more
Our team is adept at translating complex medical and scientific content with unparalleled accuracy.
Accurate translation of informed consent forms, study protocols, and other critical clinical trial documents.
Safety Translations is a leading provider of specialized translation services focused on safety-related content.
Our mission is to bridge the linguistic divide in the legal world, facilitating seamless communication
The World Trade Organization reported a yearly growth rate of 14.4% for the imports and exports of medical goods. The revised provisions and harmonized regulations have opened trade markets to multiple Tier-2 & Tier-3 countries. However, an efficient supply of medical goods cannot be guaranteed if its usage is left ambiguous to the local regulator or the end user. To address this setback, translations of medical documents are important to the local language of the member state. Many National Regulatory Authorities expect the Technical File, if not the Labels, IFUs and User Manuals, to be submitted in the local national language.
With the increasing ease of doing business globally, meeting national requirements have become equally important. Translation of critical medical documents is a necessity to ensure a hassle-free trade experience.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.