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...
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...
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...
The expiry, or near expiry, of the shelf life of a medical device can be a problem for medical device manufacturers when your device is low volume with a large minimum order quantity (MOQ) or sales have not been as forecast. This situation can have...
Shelf-life testing is a critical step in preparing a medical device for the market and is mandatory for all products. Fail to perform this testing correctly and you will likely have to recall products, and risk significant damage to your market...
The ability to accurately measure and strictly control bioburden is integral to a high standard of medical device manufacturing and assembly. It is important therefore that your medical device contract manufacturer has systems in place that ensure...
Medical sterilization is most often the final part of the medical device contract manufacturing process and there are various sterilization methods that can be used. The main ones are gamma (irradiation) sterilization and ethylene oxide (EtO)...
Medical leak and block testing is a critical medical device manufacturing process. This quality control measure is a safeguard against product failure and plays a key role in ensuring the safety and performance of your medical product. A blockage...