Cardio-Phoenix Inc. -  Now ISO 13485:2016 Certified

Cardio–Phoenix Inc. is proud to announce that it has received the coveted ISO 13845:2016 certification for the Design and Development of non-invasive diagnostic medical devices.

ISO certification of Cardio-Phoenix demonstrates the company’s quality commitment to developing advanced products and novel technology for the early detection of a broad range of heart disease in primary clinical care.

The 2016 version of ISO 13485 is rather new and few companies worldwide have been able to achieve this certification, preferring instead to stick with ISO 13485:2003 as long as possible which is a much simpler standard. ISO 13485 is on par with the standards expected by the FDA and represents the International Standard Organization’s (ISO) efforts to homogenize medical device quality standards with those of the FDA (Food and Drug Agency) in the U.S.A.

“This is the significant step in our quest for device certification.  This ISO certification represents an important milestone for our company and reflects our ongoing commitment to provide a high-quality device and to ensure that we meet and comply with regulatory quality standards”, Draženka Zoraja Nićetin, quality manager

Recognized worldwide, an ISO 13485:2016 certificate is a validation of a company’s high level of quality, reliability, and safety. Achieving ISO certification demonstrates that Cardio-Phoenix Inc. has effectively implemented a quality management system that complies with the international standard for the medical devices.

“This certification is the testament to the high level of performance and quality control customers can expect from Cardio-Phoenix Inc. The company will continuously strive to maintain the validity of its certification and remain aligned with the current medical device regulatory environment. ” according to Marc Bisnaire, CEO

Where ISO 9001 has become a worldwide standard for product quality, ISO 13485 is a much stricter and more specific standard for medical devices companies – after all, medical devices deal with patient lives and not just product quality in general.  

The medical device industry is a highly regulated industry that makes it very difficult to enter. It is not enough to have a great product but being ISO 13485:2016 certified means the company has completed the first step to entering all ISO 13485 markets. Cardio-Phoenix can now pursue CE mark, which will allow the company to sell its products throughout the European Union, one of the largest medical device markets in the world.

In 2018, achieving ISO 13485:2016 is a truly amazing accomplishment, especially as in early 2017, the ISO Governing body suspended half of the Notified Bodies that were licensed to issue ISO Certification, which particularly affected medical device companies the most. New and innovative companies were left behind as the few remaining Notified Bodies focused on their bigger customers. Few innovation companies have since achieved ISO13485:2016.

To overcome this adversity, Cardio-Phoenix worked closely with Slovenian Institute of Quality and Metrology (SIQ) who retained their status as a Notified Body able to issue ISO 13485 certification and in particular the coveted ISO 13485:2016 version. Cardio-Phoenix recognizes the expertise and commitment of the SIQ team and particularly the two auditors, Vojko Koron and Matevž Polutnik, who expertly completed the audit. Their level of experience, professionalism and vast knowledge in QMS was invaluable.  

One very important factor in Cardio-Phoenix Inc. being able to achieve ISO 13485:2016 was because it used qmsWrapperTM as their Quality Management System (QMS). Designed specifically to assist medical device companies to achieve and maintain ISO 13485:2003, ISO 13485:2016 and ensure compliance as per FDA 21 CFR 820 quality management system, qmsWrapper was crucial to Cardio-Phoenix's success. The auditors from SIQ were very impressed with qmsWrapper’s capabilities, being able to track any project task, through the QMS system, to completion, to approval, and through documentation history.

"With qmsWrapper, we were able to implement a combined project management and quality management system that effectively layered QMS as an integral part of our medical device development, without imposing another layer of management. qmsWrapper made it easy for the auditors at SIQ to review how we worked, and track everything within the QMS system…” said Marc Bisnaire, “…qmsWrapper is an amazing system, which I have to admit is really affordable, all med-dev start-ups should be using it. More importantly, qmsWrapper is also helping us be FDA 21 CFR 820 ready".
“Surprisingly, qmsWrapper is also used to create the processes and workflows which are helping us validate, document and track quality issues in our clinical protocols during our Clinical Studies”, says Ivana Krizanovic, Clinical Studies supervisor, “it’s amazing how effective it is!”


About the company

For over a decade, Cardio-Phoenix has been dedicated to the research and development of affordable, simple to use, non-invasive medical technologies. The goal is to enable at the clinical level the early detection of a broad range of common heart diseases during normal patient screening. Current state-of-the-art ECG only devices both miss and mis-diagnose far too many common heart diseases, making it ineffective and inefficient as a screening tool in primary patient care clinical use. These new technologies will prevent many unnecessary, invasive and high-risk testing of healthy patients and greatly reduce the number of false negative diagnosis – i.e. patients sent home with undetected heart disease and also greatly reduce the number of false positives that send far too many healthy patients to fill the cardiologists waiting room.

Cardio-Phoenix Inc. is a world trailblazer in evidence-based medical innovation and research in diagnostic cardiology. 

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