Medical device classification in the UK is a critical early step in bringing any product to market. Getting it right can mean the difference between product launch delays and streamlined success. Under the UK Medical Devices Regulations 2002 (as...
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Understanding Clean Room Grades and GMP Classification
08/04/2025
In cleanroom manufacturing, even microscopic contamination can mean failed compliance, product recalls and operational setbacks. For senior production and operations managers seeking a contract manufacturer, understanding cleanroom classifications...
Risk management of medical devices
11/03/2025
Effective risk management of medical devices is a fundamental aspect of ensuring their safety, efficacy and regulatory compliance. Rooted in Hippocrates’ principle of ‘First, do no harm’, it serves as a proactive approach to identifying, evaluating...
Medical Device Technical File Requirements: Your Essential Guide
11/02/2025
Medical Device Technical File Requirements: Your Essential Guide A medical device technical file is a crucial document that outlines all essential information about a medical device, ensuring its safety, performance and compliance with regulatory...
Meridian Medical Announces Exciting Updates to Quality Assurance Team
09/01/2025
Harnessing our Expert Knowledge in QA and Regulatory Affairs to Tackle Evolving Compliance Complexity As a specialist medical device manufacturer, ensuring exceptional product quality and compliance with complex regulatory requirements are central...
Overview of Gynaecological Medical Devices
11/12/2024
The field of obstetrics has undergone remarkable transformations over the years, driven by advancements in medical technology and an ever-growing understanding of maternal and foetal health. Obstetric medical devices play a pivotal role in ensuring...