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…
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…
Guidance for Manufacturers For medical devices, sterilization is, unsurprisingly, crucial to patient health. For the best results, sterilization needs to begin with the manufacturers, who…
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…
ISO 7864:2016 – Sterile hypodermic needles for single use – Requirements and test methods is the latest version of the standard that specifies guidelines for…