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...
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 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...
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...
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...
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...