Medical device companies must have established risk management processes that comply with ISO 14971.

From the health histories of patients to the effectiveness of different healthcare services, hospitals are sitting on a treasure trove of historical data.

It’s tempting to attribute the increased profile now given to occupational health and safety (OH&S) to the Covid-19 pandemic.

Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done.

Artificial intelligence (AI) is revolutionizing the healthcare industry by enhancing decision-making capabilities, improving quality of care, and reducing costs.

Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance.

I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No.

As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices.

In memory of Al Phadt, Ph.D.

On Dec. 9, 2022, the U.S.