Digital health tools, artificial intelligence (AI), and wearable devices are leading the way in transforming the landscape ...

The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...

PCCP empowers medical device manufacturers to implement updates and improvements without the traditional ... Leveraging ...

Supply chain resilience is critical in industries with high-risk products and strict regulatory demands ... Disruptions to ...

The Global Surgical Stapling Device Market is projected to be valued at US$ 3,977.40 million in 2023, with an anticipated growth trajectory reaching US$ 5,930.60 million by 2033. The market is ...

After a career as a corruption investigator, Aaron Narva had an idea for a startup in the age of LLM AI: help hospitals ...

GE HealthCare is the winner of the 2024 Silver Alexander Hamilton Award in Financial Risk Management. Congratulations!

Top Capa Software Company for Corrective Action Management In today’s fast-paced business environment, Corrective and ...

The medical device industry faces unique challenges as PFAS begins to face regulation in the U.S. and Europe despite ...

Successful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system requirements, replacing FDA audit and inspection if required Health Canada and U.S. FDA ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

They are not allowed to make medical decisions by themselves, and they can't diagnose patients or decide how to treat them. “They’re not qualified to do it," Stern said. "We run a high risk ...