Navigating Regulatory and Patent Challenges in the Combination Products Space 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 [...]

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 Lobbyists for the medical device industry have repeatedly sought to have the tax repealed, arguing [...]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 [...]