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实例探究 > How Greenlight Guru IS Laying the Foundation for Success at Amnion Life

How Greenlight Guru IS Laying the Foundation for Success at Amnion Life

技术
  • 功能应用 - 产品生命周期管理系统 (PLM)
  • 功能应用 - 企业资源规划系统 (ERP)
  • 功能应用 - 远程监控系统
适用行业
  • 医疗保健和医院
  • 生命科学
适用功能
  • 产品研发
  • 质量保证
用例
  • 预测性维护
  • 监管合规监控
  • 远程资产管理
服务
  • 系统集成
  • 软件设计与工程服务
  • 培训
挑战
Amnion Life, a startup medical device company, faced significant challenges due to their lack of in-house expertise in the medical device industry. The team was new to the field and uncertain about the necessary steps to ensure compliance and success. They were overwhelmed by the complexities of establishing processes and managing multiple ad-hoc quality systems. The anxieties included questions about whether they were doing things right, what else they needed to be concerned about, and if their processes were compliant. These uncertainties hindered their efficiency and left them feeling overwhelmed. They realized the need for guidance in implementing a Quality Management System (QMS) and understanding the regulatory requirements for medical devices. They sought a provider who could not only offer an eQMS but also serve as a partner to support their efforts.
关于客户
Amnion Life is a medical device startup founded in 2016 by Dr. Amir Fassihi. The company is dedicated to designing and developing innovative medical devices, with a focus on improving outcomes for preterm infants. Their flagship product, the AmnioBed, is a novel Class II device that recreates womb-like conditions to promote ongoing development and reduce complications following premature birth. The company operates in the highly regulated medical device industry and aims to be at the forefront of quality and regulatory compliance. Despite being a small team with limited experience in the medical device field, Amnion Life is committed to achieving high-quality outcomes and scalability. They are based in Orange County, CA, USA, and are navigating the De Novo pathway to bring their unique device to market.
解决方案
Amnion Life turned to Greenlight Guru's eQMS solution to address their challenges. Greenlight Guru provided an out-of-the-box solution specifically designed for the needs of medical device companies. The software streamlined processes and removed the regulatory burden for compliance with FDA and ISO regulations. Key features included linkages between design inputs and outputs, advanced user permissions for document control, collaboration with external partners, fully integrated risk management aligned with ISO 14971 requirements, and multi-level design control locking for digital design reviews. Amnion Life found immense value in Greenlight Guru's established workflows and user-friendly interface. The Guru Services offered by Greenlight Guru provided dedicated industry experts who became an extension of the Amnion Life team, offering clarity on quality management system matters. This partnership allowed Amnion Life to focus on strategic activities while ensuring compliance and efficiency in their design and development processes.
运营影响
  • Amnion Life experienced a seamless transition to Greenlight Guru's eQMS, finding the user interface clear and easy to navigate.
  • The team no longer had to manually manage design controls through spreadsheets and paperwork, simplifying their processes.
  • Greenlight Guru's software and services provided peace of mind, allowing the team to focus on strategic activities and avoid major setbacks.
数量效益
  • Amnion Life received enough funding to purchase Greenlight Guru's eQMS software after following their content for over a year.
  • The implementation of Greenlight Guru's eQMS allowed Amnion Life to meet FDA and ISO regulatory requirements efficiently.

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