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Greenlight Guru > Case Studies > MediBeacon's Successful ISO 13485:2016 Re-Certification Audit with Modern QMS
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MediBeacon's Successful ISO 13485:2016 Re-Certification Audit with Modern QMS

Technology Category
  • Cybersecurity & Privacy - Security Compliance
  • Platform as a Service (PaaS) - Device Management Platforms
Applicable Industries
  • Electronics
  • Healthcare & Hospitals
Applicable Functions
  • Maintenance
  • Product Research & Development
Use Cases
  • Inventory Management
  • Time Sensitive Networking
Services
  • System Integration
  • Testing & Certification
The Challenge
MediBeacon, a medical technology company, was facing challenges in managing documentation and preparing for audits with a paper-based Quality Management System (QMS) while bringing a Class III device to market. The company's Transdermal GFR Measurement System (TGFR) is a class III combination device, which means it must go through the FDA Premarket Approval (PMA) pathway. Additionally, MediBeacon had contracted with multiple device development and manufacturing organizations, and the drug component of their device had to comply with 21 CFR Part 4 - Regulation of Combination Products. The company quickly realized that a paper-based QMS or a generic software solution was not sufficient to navigate the required regulatory and management hurdles.
About The Customer
MediBeacon is a Medical Technology company that specializes in the advancement of fluorescent tracer agents and transdermal measurement. The company has multiple combination products (which include both a medical device and a diagnostic agent) in various stages of clinical development. The MediBeacon® Transdermal GFR Measurement System (TGFR) is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function. The company is focused on bringing transformational technology into medical practice with the goal of delivering products that can have a profoundly positive impact on both the quality and cost of patient care.
The Solution
MediBeacon transitioned from a paper-based QMS to Greenlight Guru, an electronic QMS (eQMS) designed specifically for device manufacturers and developers. The company chose Greenlight Guru for its intuitive user experience, ISO 13485 compliance, and the validation package it offers. The transition process was facilitated by the Greenlight Guru's Customer Success team, known as 'The Gurus', who helped MediBeacon bring everything into the system in a way that facilitated editing and the maintenance of up-to-date documents. The Gurus also provided invaluable support throughout the onboarding process, helping MediBeacon use the software confidently and efficiently.
Operational Impact
  • With the help of Greenlight Guru, MediBeacon was able to transition from a paper-based QMS to an electronic one in less than three months. This transition not only saved the company valuable time but also helped them pass an ISO 13485 recertification with zero findings. The intuitive user experience provided by Greenlight Guru's eQMS was a significant time saver for the company. The company's auditor praised the system, stating that everything they usually offer as opportunities for improvement was already being done by MediBeacon, and the system looked excellent. This successful transition and certification have set a strong foundation for MediBeacon's future product development.
Quantitative Benefit
  • 4x faster time-to-value experience with the Guru Edge
  • 3 months saved each year
  • Flawless ISO 13485 re-certification

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