Are you a medtech start-up ready to bring your innovative solution to the EU market, or an established company looking to expand your global presence? At Mastermind Translations, we understand the complexities of the medical technology industry, from regulatory compliance to market entry. With extensive experience across all classes of medical devices and IVDs, we ensure that your content is translated with precision, supporting your international success at every stage of the export process.
We fully appreciate that medical device manufacturers entering global markets face stringent regulatory frameworks, particularly in the EU. Whether it is your labels, IFUs, or software interfaces, we ensure that every piece of information is both accurate and fully compliant with the specific language requirements of your target market. By working with us, you gain a partner who not only understands the intricacies of medtech translation but also has the necessary knowledge and experience to help you navigate the complex regulatory landscape with confidence.
Why We Are Your Ideal Partner
for Medtech Translation
Expert Team of Medtech Linguists
You will experience exceptional results delivered by a dedicated team of vetted medtech linguists with the necessary life science credentials, industry knowledge, and hands-on experience to translate content for all classes of medical devices and IVDs for both healthcare professionals and lay users.
Deep Understanding of EU MDR and IVDR
We have extensive knowledge of the language requirements set out by the EU MDR and IVDR for information accompanying a medical device. We help you stay compliant by ensuring that your labels, IFUs, and GUIs adhere to the rules applicable to your device across individual EU Member States.
Client-Centred Service with ISO Compliance
Our service goes beyond ISO 17100:2015-compliant translations and includes tailored advice for the language requirements in each export market to ensure your content is accurate and market-ready.
Proven Track Record Globally
With nearly a decade of experience supporting medical device companies across the UK, EU, USA, Japan, and Korea, we have successfully helped our clients navigate complex regulatory environments and bring their products to market efficiently.
Medtech content we translate:
- R&D: scientific studies and reports, data sheets, patents, Good Laboratories Practice (GLP) documents, Standard Operating Procedures (SOPs)
- Regulatory Submission: technical files, clinical study protocols, risk management and clinical evaluation reports, EU Declaration of Conformity (DoC)
- Product Information: labels, Instructions for Use (IFUs), Graphical User Interfaces (GUIs)
- Manufacturing & Production: manufacturing specifications, production manuals, Health and Safety manuals
- Post-Market Surveillance: Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Post-market clinical follow-up (PMCF) reports, Field Safety Notices (FSNs)
- Sales: product catalogues, brochures, web content, corporate and sales communications, promotional literature