Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, ...

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to ...

The future of healthcare depends on cross-sector collaboration among regulatory, commercial, R&D, and business development teams. This integrated approach is crucial to avoiding siloed decisions that ...

AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to deliver real-time insights. This allows for prompt escalation or ...

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech ...

With the rapid growth of life tech discoveries, there is a need to adapt the patent and regulatory frameworks governing the approval, use, and protection of such discoveries. With the rapid growth of ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use. EU MDR required companies to make significant ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

In an era where sustainability is no longer a choice but a necessity, the medical industry finds itself at a crossroads. With the increasing amount of medical waste generated daily, the traditional ...

When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more ...