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

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