Author: Katie McCallum

ISO 13485:2016 emphasizes a risk-based approach to the entire QMS, shifting from the traditional risk approach which is highly product design-focused. ISO 14971-Risk Management for Medical Devices is the gold standard when it comes to applying a risk-based approach to...

The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not...

EMMA’s EMEA Regional Director Joseph Yammine explains how the EU’s General Data Protection Regulation applies to the Health Care Industry and how you can prepare your team to follow the regulation and avoid any data breaches. This webinar occurs Fridays at...

The Unique Device Identification system is used to identify the device throughout its distribution and use on the market. This system enables efficient post-market surveillance for medical device companies as well as for the FDA. FDA released a final guidance...