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...
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...
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...
In the highly regulated world of medical device manufacturing, ensuring that each aspect of your production consistently meets specification is critical. A robust Medical Device Validation Plan plays a vital role in this process. This blog will...
In the world of orthopaedic medical device manufacturing, precision and reliability are essential. At Meridian Medical, we are committed to our role as a leading subcontract manufacturer of single-use medical devices, with a rich history of...
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...