Case Studies

Industry: Medical Device ManufacturerServices: Medical Device eIFU Transition Region: Global  Background For decades, the medical device industry relied on physical Instructions for Use (IFU)—bulky paper booklets that dictated packaging size, increasing shipping costs. It became obsolete the moment a regulatory update occurred. As the industry moves toward the ‘regulatory evolution’ of electronic Instructions for Use (eIFU), many manufacturers struggle

Industry: Medical DeviceServices: Regulatory Localization Region: Global  Why ISO 13485 Alone Is No Longer Enough The transition to the FDA’s Quality Management System Regulation (QMSR) has introduced a compliance gap in the life sciences sector. While QMSR is in accordance with ISO 13485:2016, having ISO certification alone does not meet FDA requirements. Leaders must examine their systems for compliance with QMSR,

Industry: Hospitality & TourismServices: Employee Training, Brand Experience, Global ImplementationCompany region: Global Background Our client is a global leader in the hospitality industry, managing a significant portfolio of hotel brands. Their reputation relies on excellent service and a distinct guest experience for each brand. To maintain this, the company needed to standardize and improve brand culture training for

Industry: Insurance | Services: Translation & Localization  Industry: InsuranceServices: Translation & LocalizationCompany region: Global Background The Client’s Challenge: Our client, a leading global science-based company, needed to provide standardized Environment, Health, and Safety (EHS) training to its diverse, worldwide workforce. The company’s EHS Learning Division had developed a comprehensive training program that included interactive Storyline modules, workbooks, facilitator guides, and