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...

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...