How Greenlight Guru IS Laying the Foundation for Success at Amnion Life
Company Size
11-200
Region
- America
Country
- United States
Product
- Greenlight Guru eQMS
- AmnioBed
Tech Stack
- eQMS
- Design Controls
- Risk Management
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
- Functional Applications - Product Lifecycle Management Systems (PLM)
- Functional Applications - Remote Monitoring & Control Systems
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Predictive Maintenance
- Regulatory Compliance Monitoring
- Remote Asset Management
Services
- Software Design & Engineering Services
- System Integration
- Training
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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