Quality Assurance and Quality Control are both very important factors in the Medical Device Industry. But what is Quality Assurance and Quality Control and how do they differ?
5 FAQs about Medical Device Quality Assurance vs Quality Control Read More »
Here we look at the top 3 medical device quality failures recorded in history. Do you agree with our list?
Top 3 Medical Device Quality Failures Read More »
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.
IVD Directive Essential Requirements Checklist Read More »
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
A guide to ISO 13485 Read More »
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
The Benefits of ISO 9001 Quality Management System Read More »
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