Solutions: for Medical Devices and Diagnostics
Stringent healthcare regulations can slow time to market
Life sciences manufacturers bringing products to global markets face two competing pressures: intense competition and strict market regulations that affect every aspect of your product, right down to embedded software and IFU documentation. And the stakes are high. Errors or inconsistencies in translation can lead to costly noncompliance penalties and product recalls, damage your brand reputation, and put lives on the line. But sluggish time-to-market can also be fatal – to your profitability.
Tek’s solutions enable life sciences companies to address both these challenges, with the localization tools, processes and scalable resources that ensure meticulous quality and accelerate time-to-market. We help customers to apply the same rigorous quality standards to localization as they do to their manufacturing processes, delivering quality – and speed – that surpass the competition.
Quality defined: zero errors and regulatory compliance
A key requirement for all life sciences products is to be provided with the information necessary for the patient to safely use the product. Incorrect labeling, information or inaccurate translations can cause adverse reactions and pose a threat to health and safety. An absolutely accurate translation is not just "nice to have" but a matter of vital importance.
Tek’s Language Solutions for the LifeSciences industry combines knowledgeable experts, proven processes, and online business and linguistic management tools to ensure the quality of your translations and information management.
- Established web-based workflows for each type of source material (IFUs, embedded software, user interfaces for electronic medical devices, user guides and help texts) jump-start projects in order to reach regulatory compliance more quickly.
- Full conformance to regulatory requirements is ensured with a series of ISO 9000:2001 and EN 15038:2006 approved, on-demand QA standards designed specifically for life sciences companies, including language-quality inspection forms and localization style guides.
- Following its ISO approved 3-Phase Qualification Methodology, Tek selects, tests and trains subject matter experts (SMEs) and linguists, monitoring their performance against pre-agreed key performance indicators (KPIs).
- Vendor management departments are linked via the Tek OneWorld Platform for supplier registration, ranking and performance tracking with a calendar of availability, ensuring a uniform approach to scaling resources during project peaks.
- All Tek offices recruit skilled resources in their own regions, working to maximize preferred partners so that we can secure high-quality resources when needed, at the most advantageous price.
Scalable resources for project peaks and troughs
The translation of content from labels and clinical trial documentation to embedded software and user interfaces requires both available and highly-qualified in-country experts. Yet finding and managing these resources can be time-consuming, pulling attention away from your key area of business.
Tek provides you with a scalable, on-demand team of in-country experts so you never have problems meeting in-country healthcare regulations due to poor quality translations or lack of resources.
The right platform. The right knowledge.
Tek’s easy-to-use OneWorld Platform, backed by our scalable team of life sciences specialists, provides our customers with the tools, processes and industry-expert resources they need to meet global market demands for both compliance and agility. The result? Safer products and a healthier bottom line.
