Medical device manufacturing

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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Medical device industry trends in 2024 and beyond

Medical device industry trends in 2024 and beyond

As this year comes to a close, we would like to take a moment to reflect on the major trends and developments that have shaped the medical device manufacturing sector in 2024. This has been a year of evolution, technological innovation, regulatory...

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FREE Medical Device Supplier Audit Checklist

FREE Medical Device Supplier Audit Checklist

A practical, quick reference-style audit checklist A free Audit checklist to help you audit your suppliers As a medical devices assembly expert, and having worked with many medical device companies, quality assurance professionals and notified...

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Understanding Medical Device Manufacturing Costs

Understanding Medical Device Manufacturing Costs

One burning question we often get asked is, "How much does it cost to manufacture a medical device?" In this post, we'll unravel the intricacies of medical device production costs to provide you with a comprehensive breakdown. Understanding the...

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