Greenlight Guru Blog
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The Guru Edge consists of comprehensive, industry-guiding services, tools, and educational resources that accelerate your success. Greenlight Guru gives you an edge in your medical device development processes so that you can deliver life-changing MedTech. Find information on Modern Quality Management Software and Services for Medical Device Companies.
Greenlight Guru Blog
4d ago
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
Greenlight Guru Blog
4d ago
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
Greenlight Guru Blog
1w ago
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
Greenlight Guru Blog
1w ago
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
Greenlight Guru Blog
1w ago
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 Blog
2w ago
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
Greenlight Guru Blog
2w ago
This recognition underlines Greenlight Guru's commitment to innovation and customer-centric service in the MedTech industry ..read more
Greenlight Guru Blog
2w ago
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 Blog
3w ago
The premarket approval (PMA) process is the method FDA uses to evaluate the safety and effectiveness of Class III medical devices before they can be placed on the US market.  ..read more
Greenlight Guru Blog
3w ago
In Greenlight Guru’s 2024 State of the MedTech Industry Report, respondents cited a number of common challenges related to training management, including ..read more