News & Blogs

The quality management system ISO 9001 is a set of international standards to ensure efficiency and productivity in an organisation….

The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market…

The United Kingdom left the European Union on the final day of December 2020, this was before the Medical Device…

In this blog, we will discuss some of the (in our opinion) top 5 quality management system related failures. These…

Quality Assurance (QA) vs Quality Control (QC) is a commonly asked question but both are important aspects of Definition of…

Medical device failures can potentially have harmful results for healthcare professionals and patients. It is integral to avoid medical device…

This blog talks about Medical Devices Classification in the UK. A Medical device is any instrument, apparatus, appliance, software, implant,…

This blog explains the Medical Device Classification in the EU and what medical devices belong in which relevant class. The…

ISO 13485 requirements guide for: Medical Devices – Quality Management Systems – Requirements for regulatory purposes   Introduction ISO 13485…

Ensuring the safety of medical devices before they enter the market is very important. There are various regulations that must…