Greenlight Guru Case Studies Avenda Health Accelerates SaMD Product Launch with Greenlight Guru’s QMS

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	Avenda Health Accelerates SaMD Product Launch with Greenlight Guru’s QMS Greenlight Guru

Avenda Health Accelerates SaMD Product Launch with Greenlight Guru’s QMS

Greenlight Guru

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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 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.

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.

Impact #1	The partnership with Greenlight Guru has had a transformative impact on Avenda Health's operations. The QMS software, designed specifically for MedTech companies, has not only provided a robust solution for managing quality but also offered a wealth of resources for industry education. The SOP templates, courses, training workshops, and access to the Greenlight Guru Academy have been instrumental in enhancing the team's knowledge and skills. The user-friendly nature of the software has made it easy for team members of all skill levels to get started, significantly improving collaboration and efficiency. Furthermore, the ability to link to any document in the software has been a game-changer, streamlining document management and saving considerable time. With their second 510(k) clearance obtained faster, Avenda was able to bring their product to market more quickly and efficiently, all while ensuring compliance with regulatory requirements.

Impact #1

The partnership with Greenlight Guru has had a transformative impact on Avenda Health's operations. The QMS software, designed specifically for MedTech companies, has not only provided a robust solution for managing quality but also offered a wealth of resources for industry education. The SOP templates, courses, training workshops, and access to the Greenlight Guru Academy have been instrumental in enhancing the team's knowledge and skills. The user-friendly nature of the software has made it easy for team members of all skill levels to get started, significantly improving collaboration and efficiency. Furthermore, the ability to link to any document in the software has been a game-changer, streamlining document management and saving considerable time. With their second 510(k) clearance obtained faster, Avenda was able to bring their product to market more quickly and efficiently, all while ensuring compliance with regulatory requirements.

Benefit #1	Greenlight Guru's QMS enabled Avenda to obtain their second 510(k) clearance faster, allowing them to bring their product to market more quickly.
Benefit #2	The user-friendly nature of Greenlight Guru's QMS allowed for easy learning across all skill levels, saving significant time in training.
Benefit #3	The ability to create links to anything in the software increased efficiency in collaboration and document management.

Benefit #1

Greenlight Guru's QMS enabled Avenda to obtain their second 510(k) clearance faster, allowing them to bring their product to market more quickly.

Benefit #2

The user-friendly nature of Greenlight Guru's QMS allowed for easy learning across all skill levels, saving significant time in training.

Benefit #3

The ability to create links to anything in the software increased efficiency in collaboration and document management.

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Overview

Avenda Health Accelerates SaMD Product Launch with Greenlight Guru’s QMS

Operational Impact

Quantitative Benefit