Are you a European medtech start-up, ready to bring your transformative idea to a foreign market? Or perhaps you are further down the innovation pathway and keen to establish a global presence? With our extensive experience in medical technology translation, Mastermind Translations can help you take your next leap.
In today’s ever-changing and extremely competitive environment, only medical technologies with a very high added value reach the end user. This means that effectively communicating the value of what you offer in new markets has never been more important.
With our cross-sector translation expertise in life sciences and engineering, we’re ideally placed to remove any language barriers, and accelerate your product’s journey from R&D to the patient.
Whether you offer everyday items, such as spectacles or pregnancy tests, or high-tech solutions, such as artificial pancreas systems or CT scanners, you can be proud that your product makes a difference in people’s lives. However, medical technology is a complex and highly regulated industry. With the life-changing potential of your medtech product also comes the responsibility to ensure its optimal performance and safety.
We understand the regulatory pressures you’re facing, and have the knowledge and hands-on experience in medical technology translation to make your documentation fully compliant with relevant regulations.
We are the best choice for your medical technology translation project. Here’s why.
In-depth technical expertise
Translation of your product’s instructions and specifications calls for a unique combination of life science and engineering knowledge. This is what we specialise in. We can write about your medical device, because we understand how it works. Our solid technical background and relevant industry experience backed with impeccable linguistic skills are your guarantee that your document will have precisely the same meaning in another language as it does in the original.
Advanced software for consistent terminology
Every stage of medtech product development brings a breadth of new documentation that feeds into a larger set. From patent applications and manufacturing process descriptions to maintenance manuals, it’s critical that the continuity of the product lifecycle is also reflected in the translated material. We achieve that with our cutting-edge computer-assisted translation and terminology management software, so you can be sure technical terms are translated consistently across all your documents.
Stringent quality control
‘Do no harm’ is the primary tenet of medical technology product design and development. The safety of patients and healthcare professionals depends on the appropriate use of your medical device. Only accurate, unambiguous, and error-free translation of your documentation will protect the user from harm and ensure optimal performance of your product. We strictly follow the ISO 17100:2015 Standard to meet applicable regulatory requirements and, more importantly, to give you the confidence and peace of mind that your medical technology can be used safely and efficiently.
From coronavirus testing kits to swallowable drug delivery devices to portable X-ray machines, we’ve had the privilege to be involved in many medical technology translation projects. Our clients work alongside us because of what we help them achieve and they stay with us because of how we help them do it. Read on to learn more our clients’ experience.
We translate medical technology documents at every phase:
- Research and development: scientific studies and reports, data sheets, patents, Good Laboratories Practice (GLP) documents, Standard Operating Procedures (SOPs)
- Regulatory submission: regulatory compliance documents for EU and UK, CE marking technical files
- Manufacturing: manufacturing specifications, production manuals, Health and Safety manuals, product inserts and labels, Instructions for Use (IFU), software application interfaces and documentation
- Post-authorisation and marketing: Suspected Unexpected Serious Adverse Reactions (SUSARs), operating, maintenance and installation manuals, product catalogues, brochures, web content, and corporate and sales communications