FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

With the latest AICPA quality management standard, SQMS 1, firms will have to take a more holistic approach to quality.

DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

An important aspect of a pharmaceutical company is a robust quality management system (QMS) because it shows the company’s commitment to quality. This idea was introduced by the International ...

Optimize quality management documentation for SQMS No. 1. Check out these practical tips to keep documentation appropriate and comprehensive, yet right-sized. Remember, the QM deadline is Dec. 15. The ...