HeartHero, Inc., a medical device company developing a revolutionary and disruptive Automated External Defibrillator (AED), announced today that the company received ISO 13485 certification for Medical Device and Quality Management Systems. This certification is a requirement for regulatory approval and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO 13485 certificate is an internationally recognized quality standard to ensure consistent design, development, manufacture, distribution, installation, and sale of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices that consistently meet customer expectations and regulatory requirements.
“Being awarded the ISO 13485 certificate demonstrates that HeartHero has successfully complied with the laws and regulations of the medical devices industry,” said Anthony Verdeja, Vice President, Strategy and Sales for HeartHero. “This certification represents an important milestone for our company and reflects the focus we have on risk-based decision making with a commitment to safety while providing the highest-quality device.”
HeartHero’s AED, Elliot, is a trailblazing Automated External Defibrillator designed to dramatically increase the chances of survival from Sudden Cardiac Arrest. Built with ruggedness and portability in mind, Elliot is equipped with advanced machine learning, data collection, and IoT capabilities. Data collection will aid in patient treatment by providing rescuers with near real time data to allow for better clinical decisions. HeartHero is working with the American College of Cardiology in a novel collaboration to advance knowledge and improve care and outcomes for Sudden Cardiac Arrest through their data collection. Elliot the AED will also help with the current social economic and gender disparities in treatments by including language and visual representations specifically to combat these disparities in the placement of AEDs and the resuscitation process.
“This certification is further evidence of our unwavering commitment to quality and enables HeartHero to continue to develop Elliot in compliance with the highest standards of safety, product performance, and reliability,” said Gary Montague, CEO and Founder of HeartHero. “Maintaining ISO 13485 was the next step in the regulatory approval process, bringing HeartHero one step closer to CE Mark, FDA approval, and bringing Elliot to market. HeartHero also gives our deepest gratitude to Tom Renner from Vision28 for his guidance and hard work throughout this process. His help has been immeasurable.”
HeartHero is committed to positively impacting the outcome of Cardiac Arrest and to save more lives through a novel, connected Automated External Defibrillator (AED). By penetrating into the home market and identifying those at risk, HeartHero will empower them with a life-saving tool, thus accomplishing the mission of saving more lives. For more, visit hearthero.com.