Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...

Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and ...

No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that ...

MedTech leaders must find a balance between the slow, careful world of medicine and the fast-paced expectations of investors.

Protect patient data with medical IoT security. Learn how AI, Zero Trust, and encryption can prevent cyber threats and secure ...

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages.

A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from ...

FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned ...

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral ...

As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are ...

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, ...

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this ...