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Avenda Health Accelerates SaMD Product Launch with Greenlight Guru’s QMS
Technology Category
- Analytics & Modeling - Machine Learning
- Platform as a Service (PaaS) - Device Management Platforms
Applicable Industries
- Education
- Healthcare & Hospitals
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Virtual Training
- Visual Quality Detection
Services
- Testing & Certification
- Training
The Challenge
Avenda Health, a company focused on improving the quality of life and outcomes for men diagnosed with prostate cancer, faced significant challenges in bringing their novel device to market. The company's team is dispersed across the country, making collaboration across product development and quality teams difficult without a unified source of truth. Additionally, navigating the complex regulatory climate to bring their Software as a Medical Device (SaMD) product to market was a daunting task. Keeping up with requirements and documentation, while ensuring alignment across teams from coast to coast, was a top priority for Avenda. However, the remote collaboration and staying up to date with the necessary documentation proved to be a significant challenge.
About The Customer
Avenda Health is a medical technology company that uses artificial intelligence to provide physicians with a more precise and accurate cancer map than traditional MRIs. This enhanced clarity helps improve patient outcomes by giving physicians a better understanding of the extent of the disease. The company's mission is to improve the quality of life, treatment planning, and outcomes for men diagnosed with prostate cancer. To achieve this, Avenda developed a novel device and needed a powerful and intuitive Quality Management System (QMS) to bring it to market. The company's team is dispersed across the country, making collaboration and alignment on product development and quality a significant challenge.
The Solution
Avenda Health partnered with Greenlight Guru to leverage their Quality Management System (QMS), which is specifically designed for MedTech companies. Greenlight Guru's QMS not only provided a powerful solution for managing quality but also offered industry education, Standard Operating Procedure (SOP) templates, courses, training workshops, and access to the Greenlight Guru Academy. This comprehensive suite of resources dramatically improved Avenda's business collaboration on their medical device development. The user-friendly and easy-to-learn system allowed Avenda to create links to anything in the software, which proved to be a game-changer. Greenlight Guru’s eQMS and audit-ready SOP templates helped Avenda Health implement their quality system, streamline compliance, and get to market faster and more efficiently.
Operational Impact
Quantitative Benefit
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