News

ISO 9001:2015 & ISO 13485:2016 for Medical Devices
November 10, 2021

Get your complimentary copy of our latest eBook: ISO 9001:2015 & ISO 13485:2016 for Medical Devices. A definitive guide to helping you coordinate and direct your organization’s product development activities to meet customer requirements and improve effectiveness and efficiency on a continuous basis.

A Quality Management System (QMS) helps you coordinate and direct your organization’s product development activities to meet customer requirements and improve its effectiveness and efficiency on a continuous basis. Two of the FDA requirements a QMS supports is ISO 9001:2015 and ISO 13485:2016. Our latest eBook offers a quick overview.

In the definitive guide, ISO 9001:2015 & ISO 13485:2016 for Medical Devices, you’ll learn:

  • What a quality management system is and why it’s important
  • The difference between ISO 9001:2015 & ISO 13485:2016
  • How a QMS works and what it includes
  • The 5 Aspects of ISO 13485:2016
  • Management Responsibility, and more

Request your ISO ebook today.

Contact Sales

Upcoming Events

  • Shared Supplier Audit With Steri-Tek Sterilization Services
    May 6, 2022
    Fremont, CA
  • eQMS Webinar with Dot Compliance
    Stay tuned for details