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All "Iso 13485" articles

Medical Devices
• March 13, 2025

What is the FDA QMSR?

The ISO 13485 vs 21 CFR 820 binary has posed a key quality challenge for American medical device manufacturers for a long time. But now that ...
Medical Devices
• September 18, 2024

ISO 13485: the essential guide
ISO 13485
• March 13, 2024

How to choose ISO 13485 QMS Software in 2024

For medical device companies looking for quality management system (QMS) software in 2024, evaluating solutions based on ISO 13485 can offer numerous ...
Medical Devices
• January 05, 2024

8 best ISO 13485 training programs in 2024

The caliber of your organization’s ISO 13485 training has a significant impact on the success and effectiveness of your quality programs. In fact, ...
Medical Devices
• May 10, 2023

The complete guide to passing ISO 13485 audits
Medical Devices
• February 24, 2023

ISO 13485 vs. ISO 9001: understanding the key differences for medical devices
Medical Devices
• November 18, 2022

The 4 best ISO 13485 audit checklists

An ISO 13485 audit can make even the most seasoned medical device quality managers bite their nails. The standard includes 77 clauses, so there are a ...
ISO 13485
• May 13, 2021

What is the ISO 13485 Quality Manual?

Did you know that medical devices are among the most highly regulated products? Some medical devices, including those within Class II and Class III ...
ISO 13485
• October 08, 2020

The ISO 13485 Checklist for Medical Device Manufacturers

Are you preparing for ISO 13485 certification? If so, the process can be overwhelming. Keep reading to learn more about how to make the experience ...
ISO 13485
• February 27, 2020

7 ISO 13485:2016 Changes That Can Make Your Company Better

Has your medical device company lost its competitive edge? If you’re struggling to comply with quality standards, it may be time to go back to the ...
ISO 13485
• November 14, 2019

The Top 4 ISO 13485 Gap Analysis Templates: Pros and Cons

Can your medical device company pass a surprise audit? If you said "Of course we can!" then you'd be in the minority. A recent survey showed that ...
ISO 13485
• July 18, 2019

Product Realization ISO 13485 In Layman's Terms

Put simply, ISO 13485 is a set of guidelines designed to define how you should manage your Quality Management System (QMS). Managing your management ...
ISO 13485
• May 28, 2019

The Essential Parts of an ISO 13485 Medical Device QMS

Using a quality management system specifically designed for ISO 13485 is a smart move. To get the most value from a QMS, you need a solution which is ...
ISO 13485
• March 26, 2019

What An ISO 13485 Quality Manual For Medical Devices Should Look Like

An electronic quality management system (eQMS) and a defined process for compliance are critical for medical device companies. Without a clear set of ...