The main market opportunities include increasing demand for ISO 13485:2016 training, especially for new entrants or as a refresher for existing medical device professionals, offering a pathway for ...

Nine completes its QMS acquisition. Which can only mean MAFS is on its way to a digital billboard near you soon.

FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...

Even though the Dec. 15, 2025, deadline to implement the AICPA's new quality management standards has passed, many small firms that only perform preparation, compilations or reviews of financial ...

Companies in the life sciences industry must ensure they have the systems and tools to be able to consistently provide a product that is safe and effective and that is delivered in a timely manner to ...