The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a uniquely challenging regulatory environment. The complex landscape of global regulations [...]

A risk-based approach to QMS. If you’re a manufacturer of medical devices, including the medical device portion of combination products this is not the first time you’ve encountered this emphasis; the shift towards Quality by [...]

Change is an inherent part of the lifecycle of a medical device. It can affect all aspects of Current Good Manufacturing Practice (CGMP), from research and development to production and supply. Change management is a [...]

The Medical Device Tax has been a divisive issue since even before the Affordable Care Act (ACA) came into effect. Lobbyists for the medical device industry have repeatedly sought to have the tax repealed, arguing [...]

As a medical device manufacturer, you need growth and margins to be consistent. If either of these aspects are dwindling, then it may be time for you to reassess your business model. […]

The launch of a new medical device is a time of great excitement. After all, you’re creating something that could potentially improve or even save lives. While the documentation of a new medical device isn’t [...]