HeartHero, Denver, CO (2025)

10/02/2024

🎉Exciting News from HeartHero! 🎉

We are proud to announce that HeartHero, Inc. has successfully completed its annual CE Mark Audit under the Medical Device Directive (MDD), ensuring our current conformity. As we prepare for the transition to the more stringent EU Medical Device Regulation (MDR), this audit reinforces our commitment to quality, safety, and regulatory excellence.

The shift from MDD to MDR brings a heightened focus on lifecycle risk management, clinical data, and more stringent oversight by Notified Bodies—key steps that raise the bar for medical devices. This regulatory change ensures that devices like Elliot adhere to the highest standards of patient health and safety throughout their entire lifecycle. At HeartHero, we are dedicated to meeting and exceeding these new expectations as we move towards full MDR compliance.

A special thanks to Tom Renner and the Vision28 team for their unwavering guidance through this complex transition. Their expertise and dedication to regulatory precision, with no shortcuts taken, have been crucial in positioning HeartHero for success under the evolving EU requirements.

01/08/2024

The Critical Role of Mathematics in Quality-Driven Medical Device R&D

🔬 In our journey of innovation, we’ve harnessed the power of mathematics to ensure that our medical devices meet the highest standards of quality and reliability. Our recent initiative in enhancing battery connectivity, even under impact, serves as a prime example of this commitment.

🌟 “Pure mathematics is, in its way, the poetry of logical ideas.” - Albert Einstein

Einstein’s words reflect our ethos in R&D: Mathematics isn’t just about calculations; it’s the backbone of our logical and quality-focused approach. We prioritize robustness and patient safety, understanding that the true value of our work lies not in hastened financial gains but in the trust and efficacy of our medical solutions.

🛠 Quality Over Speed: A Commitment to Excellence

In a world racing for quick returns, we stand firm in our belief that quality should never be compromised. Rushing to market can lead to oversights, but our meticulous use of mathematics ensures every aspect of our devices is scrutinized and optimized. This diligence translates into products that practitioners and patients can rely on, reinforcing our reputation for excellence.

🚀 Building a Legacy of Trust and Innovation

Our focus on quality over speed is not just a business strategy; it’s a moral imperative. By placing patient safety and device effectiveness at the forefront, we are not only contributing to medical advancements but also building a legacy of trust and innovation in the healthcare sector.

Great job: Concise Engineering, Inc., Dirk Hoyns, Kevin Quintero, Justin Bushko and Michael Lemire for ensuring nothing is overlooked!

👑 Quality!

Attached Image: An R&D experiment demonstrating the applied force on a medical device to ensure battery connectivity during impact.

Yep - our device only needs 4 The Duracell Company CR123 batteries 🫶

The only AED in collaboration with the American College of Cardiology

12/11/2023

HeartHero: Where Quality Meets Innovation

🌟 “Quality means doing it right when no one is looking.” – Henry Ford

At HeartHero, we don’t just build devices; we craft lifelines. It’s why we’ve chosen to integrate a gold-plated battery door in our devices. Why gold, you ask? Because when it comes to saving lives, every detail matters.

Gold is renowned for its exceptional corrosion resistance – an attribute critical in the realm of medical devices. This choice reflects our uncompromising commitment to quality at every level, ensuring reliability and longevity in our products.

“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction, and skillful ex*****on; it represents the wise choice of many alternatives.” – William A. Foster

In life-saving situations, there is no room for error. Our dedication to superior quality in components like the gold-plated battery door is a testament to our commitment to your safety and trust.

With HeartHero, you’re not just choosing a device; you’re entrusting us with the care of your loved ones. Because we believe that when life matters, so does the quality of the devices protecting it.

Quality to start shipping in mid 2024 in approved counties. Quantity Limited!

Address

Denver, CO
80216

Website

http://hearthero.com/

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