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Understanding Medical Device Classification in the UK

Understanding Medical Device Classification in the UK

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

Understanding Clean Room Grades and GMP Classification

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...

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Risk management of medical devices

Risk management of medical devices

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...

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Overview of Gynaecological Medical Devices

Overview of Gynaecological Medical Devices

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...

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