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 […]

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 […]

3 Key Benefits of ISO 13485 Certification

Getting an ISO certification is essential for any company to ensure consistent quality and create a legitimate brand that can be trusted. However, the number of companies that are ISO certified in the United States is quite low, especially within the health services industry. ISO 13485 standard was developed to ensure quality and safety within the […]

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 […]

The Benefits And The Obstacles Involved In Performing Remote Audits

Thanks to technological advances, remote audits are becoming more popular among organizations. What was once an on-site activity, audits are now being carried out by remote techniques—especially with COVID-19 forcing organizations to work remotely for months on end.

What Are The Key Purposes Of Hiring A Business Consultant?

Running any business is not an easy task for anyone as it requires full knowledge to handle it and market demand too. There are people who seek help from the well trained and recognized agencies who are dealing with consultant services. There are numerous agencies are well offering specialized skills that would lead them to […]

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 […]