Category: Blog
The Benefits of ISO 9001 Quality Management System
Friday December 20, 2019The quality management system ISO 9001 is a set of international standards to ensure efficiency and productivity in an organisation….
UK Medical Device Requirements
Tuesday October 26, 2021The United Kingdom left the European Union on the final day of December 2020, this was before the Medical Device…
Top 5 quality management system failures
Monday January 24, 2022In this blog, we will discuss some of the (in our opinion) top 5 quality management system related failures. These…
Quality Assurance vs Quality Control
Wednesday February 16, 2022Quality Assurance (QA) vs Quality Control (QC) is a commonly asked question but both are important aspects of Definition of…
Medical device failures
Thursday February 17, 2022Medical device failures can potentially have harmful results for healthcare professionals and patients. It is integral to avoid medical device…
Medical Devices Classification UK
Monday March 7, 2022This blog talks about Medical Devices Classification in the UK. A Medical device is any instrument, apparatus, appliance, software, implant,…
Medical Device Classification EU
Tuesday March 8, 2022This blog explains the Medical Device Classification in the EU and what medical devices belong in which relevant class. The…
ISO 13485 Requirements Quality Management System
Friday March 11, 2022ISO 13485 requirements guide for: Medical Devices – Quality Management Systems – Requirements for regulatory purposes Introduction ISO 13485…
Person Responsible for Regulatory Compliance (PRRC) MDR
Thursday April 14, 2022This blog will explain the person Responsible for Regulatory Compliance (PRRC) MDR service and the necessary steps to ensure that…
Regulating medical devices in the UK
Friday July 22, 2022Ensuring the safety of medical devices before they enter the market is very important. There are various regulations that must…
