Fast-track your medical device development process without sacrificing high standards for quality and compliance. With ULG, you get language solutions crafted to meet the needs of your business and this fast-moving, strictly-regulated sector. We’ll help you stay ahead of the curve with our deep regulatory expertise, so you can navigate new regulations like the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) with ease. Rely on us to keep your business compliant and competitive in any global medical devices market.
Partner with ULG:
Guarantee compliance for your medical device development initiatives with language solutions designed for the latest global regulatory and quality benchmarks. ULG specializes in FDA and EMA-aligned translation for medical device manufacturers, along with compliant language services for other markets around the world. Navigate regulatory shifts, like the MDR and IVDR, effortlessly with support from our experts and project managers. You can rely on our workflows, certified in compliance with ISO Standard 13485 for quality management for medical devices, to meet the highest international standards of compliance and quality.
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Deliver the innovations you need to stay ahead in the fast-paced medical device sector by embracing advanced tech-powered language solutions. Our groundbreaking language asset management technology slashes turnaround times by up to 50%, enhancing efficiency without sacrificing quality. From AI-powered machine translation engines customized with industry-specific data to our proprietary system, OctaveTMS, we deliver a streamlined experience that accelerates market entry with timely and accurate translations.
The medical device industry faces unique challenges, from navigating complex medical device translation requirements to adapting quickly to technological advances. Not all medical device language services companies are equipped to navigate these challenges. For over 40 years, our team has been honing our expertise in the life sciences and medical device industries, making our team uniquely qualified to overcome these sector-specific challenges.
With 40+ years of experience, we know how important it is to stay on top of the fast-paced, ever-shifting world of life sciences regulations. Our team of regulatory experts stays ahead of these changes to make sure our work is compliant with FDA, EMA, and other global standards.
We offer MDR and IVDR consulting to help your organization implement compliant translation and interpretation practices.
Regulatory compliance is embedded into every step of our processes. We prioritize confidentiality and security, with data protection protocols certified to HITRUST and ISO 27001 standards to safeguard your information.
From multimedia solutions for training videos to Instructions for Use (IFU) translation, we provide a comprehensive package of solutions for the medical device industry, including:
We also offer medical interpreting services for any situation where clear spoken communication is a must, including but not limited to training sessions, meetings, product demos, tech support, patient consults, and regulatory audits.
Quality starts with our network of linguists, all of whom are experts in medical language translation with a minimum of 5 years' experience, advanced degrees and a proven track record. Only 10% of applicants make it through our rigorous linguist qualification process.
Beyond that, we follow stringent quality control processes, and we’re constantly making adjustments based on our quality monitoring and feedback from Language Quality Assessments.
Our quality management processes and procedures are certified to the following standards:
We harness a variety of innovative technologies to deliver high-quality translations at scale.
Our approach includes:
Volume and speed are necessities in the life sciences industry, and our team is prepared to deliver on both counts without compromising quality.
We use our state-of-the-art technology, including OctaveTMS, and a dedicated team of professionals to blend speed with accuracy, so that your project not only meets deadlines but also compliance standards.
Absolutely. Our OctaveTMS platform has ready-made integrations with tools like Veeva Vault and Adobe Experience Manager, plus we have an API to integrate seamlessly with your content management system.
Partner with ULG for medical device language services powered by pioneering technology and extensive expertise. Accelerate your global expansion with our efficient, compliance-focused solutions.
