ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories has been released. This standard specifies the general guidelines for the competence, impartiality, […]
Human factors, or ergonomics, strives to understand the interactions among humans and the other elements of a system. Integrating human factors engineering, otherwise known as […]
International standard ISO 21528-2: 2017: Microbiology of the food chain – Horizontal method for the detection and enumeration of Enterobacteriaceae specifies a method by which users […]
With the trust patients have in their doctor, whether ophthalmologist, gynecologist, pediatrician, or dentist, it is expected that the doctor has completed thorough risk analysis […]
Workplace lighting is a very nuanced subject, especially when the psychological and physiological effects that poor lighting can have on people are taken into account. […]
ANSI/AAMI/IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes – Amendment has been released. This document is an amendment to the existing ANSI/AAMI/IEC […]
Guidelines for Manufacturers For medical devices, sterilization is, unsurprisingly, crucial to patient health. For the best results, sterilization needs to begin with the manufacturers, who […]
Pharmaceutical excipients are essential to the safety, quality, and efficacy of drug products, as they impact a variety of factors influencing how a drug enters […]
Contract sterilization is rapidly growing within the medical device industry, as contracting the sterilization of manufactured health care products to an external organization simplifies the […]
In our last post, we discussed the changes made to ISO 7864:2016, the standard for sterile hypodermic needles for single use. However, ISO 7864 was […]
