FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed to prepare industry for the February 2, 2026 effective ...

Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. FDA has published and makes available ALL regulations required for medical ...

Although there is a wide range of important aspects to consider when working in the pharmaceutical industry, one of the most crucial objectives is to create effective and safe medications for patients ...

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.

All firms that perform accounting or attest engagements must have their new quality management system in place by Dec. 15, 2025. These new standards require firms to develop quality objectives around ...

How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...

A lack of quality can cost an organization millions of dollars in rework, scrap, recall, or even liability lawsuits. This industry brief shows how a quality management system (QMS) with the right ...

Qase3D introduces MDR system form hospital 3D labs - a practical, legally grounded path to MDR compliance for Point-of-Care manufacturing.