What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device. SaMD devices also need to meet the...
Jira and Confluence are popular tools for project planning and collaboration. The idea of leveraging these tools as a Quality Management System (QMS) may seem logical for businesses already utilizing them. However, despite their familiarity, Jira and Confluence are...
Ensuring regulatory compliance and fostering trust in products are paramount for medical device manufacturers. The FDA, European Competent Authority, and Health Canada closely oversee design, development, and manufacturing for patient safety and efficacy....
Back in 1993, the concept of IoT, fitness tracking apps or computerized surgical equipment sounded like something of Star Trek. But in 2023, tech is everywhere - and our medical devices have evolved for the better due to this. However, with evolution, also comes the...
The FDA plays a pivotal role, setting the gold standard for regulatory oversight. Manufacturers must meticulously adhere to FDA regulations, such as the Quality System Regulation (QSR) under 21 CFR Part 820, governing key aspects like design controls, production...
There is an intrinsic value of identifying trends in data for medtech manufacturers. Yes, the prospect of avoiding scrutiny from federal auditors is a tangible benefit. However, the true motivation for proactive medical device trend analysis lies in its power to...
The journey from concept to market-ready medical device is no easy feat. The regulatory economy, development and legislation is intricate. Understandably, compliance with standards is non-negotiable to ensure the safety and efficacy of medical devices. One such...
In a year of unexpected twists, the medical technology (MedTech) industry finds itself amidst shifting sands. So, Greenlight Guru’s 2023 MedTech Industry Benchmark Report is a treasure trove of insights into MedTech trends and the landscape. Let's deep dive into some...
The FDA compliance standards bring nuanced compliance considerations to your sector, don’t they? In pharmaceuticals or biotech, system reliability is essential. And, central to that is Computer System Validation (CSV). Essentially, it demonstrates a commitment to...
Are you a medical device manufacturer seeking to overcome the challenges of your current quality management? Let me help you show you the light. In this blog, we will show you the advantages of adopting an Enterprise Quality Management System (eQMS). Better yet, one...
Medical device companies face complex quality management challenges and strict regulatory requirements. An electronic quality management system (eQMS) like Greenlight Guru, can help companies ensure compliance, improve efficiency, facilitate collaboration, and scale...
Medical devices manufacturers can now benefit from Jira integration with Greenlight Guru. The only electronic quality management system (eQMS) specifically designed for medical device companies. This Greenlight Guru integration with Jira creates an agile system for...