Various Standards Governing Translation for Medical Devices
We often forget that there is a system in place that makes things possible. An American product that reaches a person in India went through many stages. It isn’t just the manufacturer and the distributor that should be credited for making sure the product reached India. There are a lot of steps in between that people often underestimate the importance of. Although all of us watch ads often, we don’t realize how important they are for businesses. A company cannot survive in a foreign market without a good marketing strategy. And it isn’t just the fashion industry that has to advertise itself; medical devices manufacturers have to try just as hard to win over their potential audience.
Translation of Medical Devices:
What is a medical device, you may ask? Well, a medical device is something which makes it possible for a healthcare professional to diagnose and treat their patient. The diagnostic process will not reach a conclusion without an MRI scan in some cases. But no one ever pays attention to the MRI scan machine. No one ever asks where the machine has come from. There are big corporations that manufacture medical devices and then distribute them all over the world.
As every country has decided to test modern healthcare techniques, localized versions of medical devices have become a necessity. Without the translation of medical devices, a lot of healthcare professionals and their patients will remain deprived of the benefits of modern inventions. However, the translation of medical devices is very complex. There is no room for error, as it is people’s lives that are at stake. The wrong instructions can be dangerous for a patient and also damage the machine itself. It is important for manufacturers to get quality translations if they want their devices to work properly everywhere in the world.
Various Standards Governing Translation for Medical Devices:
Sometimes, even the experts need a little guidance. A group or committee can come together to make a set of rules to resolve all issues. Rules can make anything seem simpler. This is why there are various standards today that govern the translations of medical devices. Thanks to these standards, the mistakes in medical translations has reduced by a huge percentage. The improved quality of medical translation means good things for both patients and healthcare providers. Here are the various standards that govern translation for medical devices:
ISO 9001:2018
It is not a quality standard directly related to the medical or translation fields; however, it does provide some guidelines. It explains the quality management system standards that every healthcare expert and language service provider must follow. It states that everything should be done professionally. It is up to the sellers to prove that they have followed all the quality guidelines.
ISO/TS 11669:2012
This is a quality standard that is directly related to translation services. It explains in detail the phases of the translation process and what each of them means. It also divides the duties between buyer and seller. It explains the quality process and provides guidance related to language services to the buyers.
ISO 17100:2015
Equivalent to the EU 15038:2006, this standard focuses on language service providers. It covers the process of translation of a company and the techniques it applies to complete its projects. It also covers the quality assurance systems that a company has in place. If a company is certified with this standard, that means they will be able to provide you with quality translations every time.
ISO 13485:2012
Created for medical device manufacturers, it focuses on the quality management system such corporations should have in place. A company with this standard is the one that can be trusted by healthcare professionals. They know that such a manufacturer knows what they are doing and will take good care of people’s medical needs.
Finding the Right Standards:
Whenever you are in need of quality translations, you can ask a company for its work samples or check its rating on Google. But when you need linguistic assistance with medical devices, then you should ask an agency about their certifications. The standards governing the translation of medical devices are not taken lightly. You won’t see a poorly performing company have any certification.
But checking the details of a company online is not a bad idea either. You can check both their Google rating and ISO certifications. Once you are certain that a company can provide you with the best linguistic solutions, you can go ahead and hire them. It is important to remember that making the right choice is crucial in such a situation. Medical devices can help a doctor in making the right diagnosis. A simple error can affect everyone involved in the diagnostic and treatment process but especially the patient. The patient’s health should never be at risk because of a faulty translation.
If you don’t want to risk the health of patients by saving money on translation, then hire the right agency today and get their help. Once you have the accurate translations with medical devices, using them will become easier. More patients will get the correct diagnosis and start their treatment early to achieve the desired results. It all comes down to the people who are willing to make some effort for the world and its population. If you don’t want medical devices to lose their uselessness, then you should get their manual translated as soon as possible by qualified professionals.
