In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations ..read more

In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group ..read more

The regulatory pathway for getting a Class III medical device to market in the US is known as Premarket Approval (PMA). Given that Class III devices pose the highest risk to patient safety, the PMA process is lengthy and requires a large amount of information about the device and the data backing up its safety and effectiveness claims.  ..read more

In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry ..read more

For many MedTech companies, especially those that manufacture high-risk devices, clinical trials are a crucial part of getting medical devices to market and keeping them there. In fact, clinical activities, both pre-market and post-market, were some of the top business objectives that respondents to our 2024 State of the MedTech Industry Benchmark Report told us they were focused on this year ..read more

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector ..read more

If there is one universal truth in MedTech clinical trials, it is that your study will take more time than you allot for it initially. Everyone, and I mean everyone, underestimates the amount of time their clinical studies will take ..read more

Greenlight Guru Clinical's recent introduction of Custom Collaborator Roles provides vital support to the MedTech clinical study arena. This feature brings a targeted solution to the challenges of managing large, multi-site clinical trials and surveys, focusing on the intricate needs of user roles and permissions management across many users ..read more

This recognition underlines Greenlight Guru's commitment to innovation and customer-centric service in the MedTech industry ..read more

If there is one universal truth in MedTech clinical trials, it is that your study will take more time than you allot for it initially. Everyone, and I mean everyone, underestimates the amount of time their clinical studies will take ..read more