Thought Leadership
Smith & Nephew Saves $200k Annually While Meeting MDR & IVDR Stringent Vigilance Requirements
Part of TransPerfect's GlobalLink suite of productivity applications, GlobalLink Now is a simple, but powerful way to access secure, customized AI. The system has an intuitive UI for sign on and engagement, making the application easy to use and adopt. ...
Clinical Evidence in Digital Health: Considerations for Multi-Country Evidence Generation
The global adoption of digital health solutions has revolutionized healthcare delivery, offering unprecedented opportunities for innovation in patient care, diagnostics, and disease management. However, the generation of robust clinical evidence to support these technologies...
Lessons Learned from SCMS Deployments in Global Medical Device Documentation
Transitioning to modular content using a Structured Content Management System (SCMS) has the potential to transform medical device documentation by streamlining authoring and automating content updates and publishing. For a truly successful implementation, however, early planning...
Xtalks Webinar: Artificial Intelligence and Structured Data: Driving Process Efficiency for Medical Device Manufacturers
Since the advent of artificial intelligence (AI), medical device manufacturers have been early adopters for product enhancements. Now, manufacturers are evaluating their regulated content and other production processes for suitable applications of AI and automation technology. ...
MedTech Summit EU 2024 | What's Past is Prologue: Evolution (and Future) of AI and Content Automation
Content automation technologies have been developing for 70 years – MDR and IVDR have accelerated this development, as well as adoption across the device industry. And, while product-related applications for artificial intelligence (AI) generate attention-grabbing headlines, the...
Strategic Artificial Intelligence (AI) Implementation for Medical Device Companies
Medical device companies are leveraging artificial intelligence and machine learning to streamline regulated medical device content work streams, including labeling, marketing, and PMS reporting. Learn about implementing a strategic AI program and discover how top medical...
Meeting the MDR & IVDR Content Challenge: New AI and Automation Solutions for New Requirements
The European Union's introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) marks a significant shift towards enhanced transparency in the medical device sector. While these regulations are designed to strengthen patient safety...
Medical Device Regulation: Less Time Than You Think?
In order to take advantage of the MDD extension, device manufacturers must comply with several near-term deadlines and plan for long regulatory turnarounds – the extension provides less time than you might think! Learn how TransPerfect can help you meet the impending MDR and IVDR...
Intelligent Automation for MDR & IVDR Content: Summary of Safety & Clinical Performance (SSCP), Summary of Performance (SSP), and Selected Labeling
Content requirements under the EU’s MDR and IVDR, including the translation of labeling, marketing, SSCPs, SSPs, and clinical communications, are set to dramatically increase. Currently, most device manufacturers use manual processes and document-based applications like Microsoft...
Content Automation to Meet MDR & IVDR Requirements
Marc Miller, President of TransPerfect's Medical Device Solutions chatted with experts from Takeda Pharmaceuticals & QServe to learn about MDR & IVDR labeling compliance while cutting risk, cost, & turnaround by using structured content, process automation, &...
Content Solutions for MDR & IVDR Readiness
The implementation dates for MDR (May, 2021) and IVDR (May, 2022) are fast approaching and non-compliant manufacturers are putting their EU market access at risk. These new regulatory requirements have created a “tsunami” of increased content requirements—especially in critical...