Auditing for AS9100, ISO 9001 and ISO 13485: Your Comprehensive Guide

Introduction AS9100, ISO 9001, and ISO 13485 are three of the most widely recognized quality management system (QMS) standards in the world. Organizations that achieve certification to these standards demonstrate their commitment to providing high-quality products and services that meet customer and regulatory requirements. Auditing is an essential part of QMS maintenance and improvement. By…

Medical Device

ISO 13485 Series Medical Device Master ISO 13485 compliance and stay competitive with our Medical Device Trainings. Stay ahead in the dynamic field of medical devices with APEX QA's comprehensive training programs. Our courses are designed to equip professionals with the knowledge and skills needed to navigate complex regulatory landscapes and ensure compliance with ISO 13485…

Consulting

Together, for a better tomorrow. QA Consulting Together, for a better tomorrow. QA Consulting Let's Work Together Step One Get in touch with an Apex representative who will carefully assess your organizations specific needs, goals and desired results. Step Two Together a tailored plan will be created putting the best consultant on the job to fit the needs…

The FDA QMSR Final Rule: Get Ready for a Quality Management System Revolution (and Why You Need to Act Now)

On January 31st, 2024, the FDA released its final Quality Management System Regulation (FDA QMSR) rule, marking a significant shift in the landscape for medical device manufacturers. This new rule aligns the FDA's requirements with the international standard ISO 13485:2016, creating a more harmonized and efficient regulatory framework. While the rule doesn't go into effect until February 2nd,…