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Greenlight Guru

Design Controls Best Practices for Medical Device Companies

Design Controls Best Practices for Medical Device Companies

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....

The Power of Trend Analysis in Drug Development with eQMS Platforms

The Power of Trend Analysis in Drug Development with eQMS Platforms

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 Tools For ISO 14971 Compliance for Medical Device Manufacturers

The Tools For ISO 14971 Compliance for Medical Device Manufacturers

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...

Best Practices for Successful eQMS Implementation

Best Practices for Successful eQMS Implementation

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...

Jira Integration For Greenlight Guru: Top 3 Reasons To Do It

Jira Integration For Greenlight Guru: Top 3 Reasons To Do It

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...

2022 Guide: Software as a Medical Device (SaMD)

2022 Guide: Software as a Medical Device (SaMD)

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...

SPK and Associates Partners with Greenlight Guru

SPK and Associates Partners with Greenlight Guru

Accelerating Product Development to Improve Patient Outcomes SPK and Associates, a leading woman-owned technology consulting company, today announced its partnership with Greenlight Guru, pioneer of the only dedicated Medical Device Success Platform (MDSP) to...