Pal International, a global leader in infection control products, and Mastermind Translations, a specialised language service provider for life science industries, are pleased to announce their strategic partnership aimed at supporting Pal International’s presence in over 50 overseas markets.
This partnership is rooted in a shared commitment to excellence, quality, and innovation. Its objective is to streamline translation workflows and ensure regulatory compliance of information supplied with Pal International’s products.
Originating from Pal International’s request to translate regulatory documentation, Mastermind Translations provided not only translations but also invaluable suggestions to ensure compliance with the latest EU regulations for Class IIa medical devices. This added value led to the expansion of the collaboration to several more multilingual projects.
What Makes Mastermind Translations the Right Partner for Pal International?
Mastermind Translations, distinguished by its exclusive focus on life sciences, and medical devices in particular, offers a unique combination of in-depth industry knowledge and regulatory expertise. This bespoke offering enables its team of experts to go beyond conventional translation services and deliver comprehensive linguistic solutions tailored specifically to the complex needs of clients in highly regulated industries. This expertise is especially valued in an industry as diverse and innovation-driven as medical devices, where products can vary greatly, from everyday items to complex medical equipment for healthcare professionals, to in vitro diagnostics (IVDs), to software as a medical device (SaMD).
‘At Mastermind Translations, we pride ourselves on being a value-added translation service,’ says Katarzyna E Slobodzian-Taylor, Director of Mastermind Translations. ‘Our expertise in life science industries enables us to support Pal International with practical assistance, from advising on regulatory compliance of written information to managing regulated terminology across projects.’
This level of specialisation sets Mastermind Translations apart from traditional translation companies whose project lifecycles are often not designed for bespoke expert support beyond the core translation process.
By addressing operational pain points comprehensively and offering client-centred solutions, Mastermind Translations improves time and cost-efficiency for Pal International. This has contributed to streamlining the manufacturer’s pathways toward successful growth in global markets.
How Does Mastermind Translations Ensure Quality Translation for Medical Devices in Its Translation Projects?
Quality is crucial in medical device translation projects and should be maintained in all aspects of the translation process. It starts with carefully selecting a team of vetted native-speaking translation professionals with the appropriate expertise for each request. Medical technologies can be very complex, so it is important that these linguists have strong life science credentials and experience in specialist or niche areas, such as infection control and microbiology. Many of the linguists have life science degrees and hands-on experience in life science industries.
Mastermind Translations maintains a rigorous translation process that includes translation and independent revision as well as quality assurance checks. This multi-layered approach and attention to detail ensure accuracy and fitness for purpose. To improve productivity and enhance consistency, cutting-edge solutions are used, such as computer-assisted translation tools, including translation memory and terminology management tools, as well as AI-powered machine translation systems if appropriate. When used correctly, these can significantly leverage the human translation process for repetitive or less technical content.
With a team of expert medical device translators, Mastermind Translations can handle a variety of medical device translation projects, from proofing multilingual label artwork, to translating instructions for use (IFUs), to localising graphical user interfaces (GUIs) for medical device software (SaMD or SiMD).
Why Is Quality Language Translation Not Enough for Medical Device Documents?
With the medical device industry becoming increasingly global, translating medical device material accurately is critical for safety. However, accurate translation alone is not sufficient for international success. Medical technologies are accompanied by a wide range of information, such as instructions for use (IFU), labels, graphical user interfaces (GUIs), field safety notices (FSNs), and declarations of conformity (DoCs), which all must meet specific regulatory requirements of the markets where the products are made available to the user. Translation requirements in those markets can also vary greatly, depending on the device class, intended user, and type of information. Medical device companies often need support navigating this very complex landscape.
Mastermind Translations has the expertise to ensure that its translations not only maintain the integrity of the original content but also meet regulatory language requirements of different jurisdictions. This allows manufacturers to operate in their export markets with confidence.
How Has Pal International Benefited from Medical Device Translation Services Received from Mastermind Translations?
The positive feedback received from Pal International further underscores the efficiency of Mastermind Translations’ work. ‘We are very pleased with the exceptional translation quality and speedy turnaround provided by Mastermind Translations,’ says Pal International’s Regulatory Affairs Manager. ‘Our Italian partners have confirmed the excellence of the translations, while our Portuguese partners have described them as “perfect”.’
‘We are delighted to receive such positive feedback from Pal International’s in-country partners,’ adds Katarzyna. ‘It reaffirms our unwavering commitment to our clients’ success. We look forward to continuing to leverage our expertise to support Pal International with their international activities and expansion efforts.’
This testimony highlights the tangible benefits that medical device manufacturers can experience by partnering with Mastermind Translations, including high-quality translations, regulatory compliance advice, swift project delivery, and positive reception from international stakeholders. Such outcomes reinforce the value of working with a specialised translation service provider focused on the medical device industry.
Pal International represents the latest addition to the growing number of Mastermind Translations’ high-profile clients, drawn to its deep understanding of their industry and ability to alleviate operational burdens. Among its recent clients are global pharmaceutical companies medac and HIPRA.
Key Takeaways:
- Expert Medical Device Translation Services
Pal International’s partnership with Mastermind Translations highlights the critical role of expert medical device translation services in ensuring high-quality and compliant translations for the medical device industry. - Regulatory Compliance Expertise
Mastermind Translations’ deep understanding of the medtech sector guarantees accurate translations that meet the stringent regulatory requirements of various jurisdictions, including the European Union’s Medical Devices Regulation (EU MDR) and In Vitro Diagnostics Regulation (EU IVDR). - Navigating Regulatory Requirements
This collaboration underscores the importance of partnering with a professional medical device translation company to navigate the complex regulatory requirements of different export markets, facilitating Pal International’s global expansion. - Efficiency in Global Operations
By working with Mastermind Translations, Pal International benefits from more efficient translation solutions, streamlining its operations and ensuring compliance across its 50 overseas markets.