Medical devices must be of high quality to be considered safe on the market. Strict safety and quality regulations must be met to achieve this.
Medical devices are essential pieces of equipment, and there are a lot of them out there on the market. In this blog, we’re looking at
Ensuring the safety of medical devices before they enter the market is very important. There are various regulations that must be followed based on the
This blog will explain the Person Responsible for Regulatory Compliance (PRRC) MDR service and the necessary steps to ensure that your medical device is compliant
ISO 13485 requirements guide for: Medical Devices – Quality Management Systems – Requirements for regulatory purposes Introduction ISO 13485 can be used by organisations that
This blog explains the Medical Device Classification in the EU and what medical devices belong in which relevant class. The European Union (EU) device classification
This blog talks about Medical Devices Classification in the UK. A Medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article
Quality Assurance (QA) vs Quality Control (QC) is a commonly asked question but both are important aspects of Quality Management Systems (QMS). They work side
In this blog, we will discuss some of the (in our opinion) top 5 quality management system-related failures. These failures had massive consequences, including loss
The United Kingdom left the European Union on the final day of December 2020, this was before the Medical Device Regulations EU 2017/745, and In
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