Noah Labs receives ISO 13485 certification as a medical device manufacturer
What is the ISO 13485 certification?
The ISO 13485 is an international standard that specifies quality management system (QMS) requirements tailored to organizations involved in the design, development, manufacture, installation, and maintenance of medical devices and related services. A company must implement and maintain a quality management system that meets the requirements of the standard in order to be certified to ISO 13485.
Why this is important to Noah Labs and what it means for our patients
For Noah Labs, this certification is not just a badge of honor; it is a testament to our dedication to providing world-class products and services in the healthcare industry, where safety, accuracy and reliability are critical. It demonstrates that our company has documented processes in place, follows best practices, and strives for continuous improvement.
This assures our patients that our quality management system maintains the highest standards for all of our services. We are pleased to have received this certification and are committed to providing you with the most advanced medical solutions to improve your quality of life.
Is your company considering ISO 13485 certification?
Here are some tips:
- Start by defining the intended use of your medical device, product and/or service.
- Identify and understand all applicable ISO standards required by your organization.
- Analyze your company's gaps and make the necessary adjustments within your company.
- Select the right certification body to perform the external audits and approvals.
- Be patient during the demanding certification process, as it will require an investment of time, money and effort from each team member.
While it may seem overwhelming at first, this investment will provide you with significant benefits in the long run by serving as your ticket to the healthcare industry.
About Noah Labs
At Noah Labs, our mission is to help people with cardiovascular diseases live longer, healthier lives. With Noah Labs Ark, we have created an environment where a patient's health is independent of location and where intelligent algorithms detect deterioration early so that physicians can take timely countermeasures. We are developing software systems that understand, treat and ultimately prevent cardiovascular disease. Noah Labs is funded by EIT Health and the State of Berlin. We are also currently conducting clinical studies with Charité University Hospital in Berlin, UMC-Maastricht and Clinic Barcelona.
At Noah Labs, our AI-powered approach to cardiovascular care and research is dedicated to helping people with cardiovascular disease live longer, healthier lives. The Noah Labs Ark cardiovascular software platform enables cardiologists to efficiently monitor patients with heart failure through telemedicine, utilizing external measurement devices such as smartwatches, blood pressure cuffs, and scales. These devices wirelessly transmit health data to the Noah Labs Ark, where it is continuously analyzed, allowing doctors to detect changes early and respond immediately.
In addition to this, we are developing innovative voice-based machine learning software designed for the early detection of decompensated heart failure - the leading cause of hospitalization. This cutting-edge technology analyzes changes in vocal tone caused by pulmonary edema and fluid accumulation, detecting deterioration up to 14 days before current standard methods. By doing so, it helps avoid costly hospitalizations. Our patented solution is undergoing testing at prestigious institutions including the Mayo Clinic in the USA, Charité in Berlin, and university hospitals in Maastricht and Barcelona.
Founded in 2021 by physician Dr. Leonhard Riehle, machine learning engineer Marcus Hott, and serial entrepreneur Oliver Piepenstock, we are an ISO 13485 certified manufacturer of software-based medical devices, currently employing 20 dedicated professionals.