Innovative Health Receives ISO 13485:2016 Certification for its Quality Management System

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The national medical device reprocessing company successfully completed all certification requirements and also recently received a FDA audit with no 483 deficiencies.

Innovative Health

Innovative Health

We want to give our customers and business partners the highest level of confidence in our processes and products, and we are willing to go the extra mile to achieve that aim.

Innovative Health, a national leader in medical device reprocessing for the cardiology sector, just announced it has received ISO 13485:2016 certification for its quality management system. The company received the certification based on a comprehensive audit by BSI, a global business standards firm with expertise in helping organizations comply with these standards.

ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies. ISO standards are built by gaining consensus from committees of leading technical experts from around the world and typically take three years to create and finalize. These experts include individuals from the relevant industry as well as those from consumer associations, academia, NGOs and government bodies.

ISO 13485:2016 requires that organizations demonstrate the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. BSI's on-site visit of Innovative Health's Scottsdale-based facility focused on areas ranging from production processes and document control to product validation and shipping. The audit included a comprehensive evaluation of Innovative Health's production areas as well as various management reviews, an evaluation of customer feedback and in-depth meetings with its leadership.

Innovative Health also recently completed its first FDA inspection, with no 483 deficiencies documented as part of its Establishment Inspection Report (EIR). Many companies receive warning letters or recommendations for voluntary improvements, but in this case, the FDA reported no objectionable items based on its three-day, on-site audit of Innovative Health's facility.

"Innovative Health is pleased to showcase our commitment to quality through this certification and the incredible result of our recent FDA audit," said Rick Ferreira, CEO of Innovative Health. "We want to give our customers and business partners the highest level of confidence in our processes and products, and we are willing to go the extra mile to achieve that aim."

As a medical device reprocessor, Innovative Health employs state-of-the-art technology to clean, test and sterilize costly devices used in some of the most advanced cardiac procedures. The company's high standards of quality and safety in its reprocessed devices exceed those of the original "single use" products as these are 100% inspected. These devices include diagnostic, ultrasound and mapping catheters as well as other electrophysiology devices.

About Innovative Health
Innovative Health is an advanced medical device reprocessing company that offers smarter utilization of medical devices in hospitals' cardiology and electrophysiology programs, saving some labs more than $200K per year. The company was founded in 2015 by industry veterans to pursue a more aggressive and more scientifically advanced product development strategy than other reprocessors, helping hospitals save more from reprocessing.

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Sarah McLeod
Activate Health
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