5 FAQs About ISO 13485 Answered

For medical device manufacturers, ISO 13485 is the most reliable, internationally recognized standard of quality management. The ISO 13485 standard mentions all the requirements that an effective quality management system in the medical device industry should meet. Some of the most common questions about ISO 13485 are discussed below: 1. What’s Difference About ISO 13485:2016? Several changes […]

4 ISO 13485 Changes That Can Help You Gain A Competitive Edge

The 2016 update to the ISO 13485 standard brought about some notable changes for companies to focus on. If your company has been underperforming, it might be time to lean into the requirements of the standards and capitalize on these changes. Not only will you ensure that the medical devices you’re manufacturing are of the […]

ISO 13485 – It’s Purpose and Need Explained

If you’re in the medical device industry, you probably have a Quality Management System that’s a combination of paper-based processes and general tools in command of document control. Although this works— and probably has been working for you– this method is full of risks. So what to do when you’re using a highly risky, non-scalable […]

Guide to Writing an ISO 13485 Quality Manual

ISO 13485 is a regulatory standard that specifies the requirements of a quality management system (QMS) for organizations manufacturing medical devices. The standard requires the company to prove its ability to deliver medical devices and services that meet the customer requirements as well as the applicable regulatory requirements under the ISO certification consistently. The organization can […]

How to Gain ISO 13485 Certification for your Medical Device Company.

If your company makes medical devices, then you need to know how ISO 13485 can help you to develop a comprehensive management system for designing and making all medical devices. How does ISO 13485 help with Quality control for your manufacturing business? ISO 13485 requires that a business show that they have a quality management […]