Top 3 Medical Device Quality Failures
Here we look at the top 3 medical device quality failures recorded in history. Do you agree with our list?
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IVD Directive Essential Requirements Checklist
The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic (IVDR) medical devices. It also includes the requirements for each device’s technical documentation. The information can vary based on the classification of the device, but it is always the main piece of evidence within the essential requirements.
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A guide to ISO 13485
ISO 13485 Quality Management System Implementing quality management system (QMS) iso 13485 couldn’t be easier with our step by step guide. A quality management system is necessary in medical compliance. A QMS is simply a set of tools, processes or procedures put in place to offer high quality. The most recent version of the iso
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The Benefits of ISO 9001 Quality Management System
The quality management system ISO 9001 is a set of international standards to ensure efficiency and productivity in an organisation. It is known as the base of a quality system. ISO 9001 is a management system that can be used to provide a solid foundation for a business. It can have a positive impact on
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