Innovative Health

24/07/2025

“On June 5, the U.S. District Court for the Central District of California entered judgment on the verdict in favor of Plaintiff Innovative Health LLC and against Defendant Biosense Webster, Inc.” Read Innovative Health’s newsletter:

21/07/2025

Guarding Against the Weaponization of Supply Chain Resilience in Healthcare Purchasing

Some health systems weaponize supply chain resilience to drive unreasonable demands from healthcare suppliers.

15/07/2025

Devices that do not adhere to Innovative Health’s strict standards are rejected through quality inspections or testing. See our video about how Innovative Health’s quality system permeates everything we do:

08/07/2025

Unlike normal production facilities, a single-use device reprocessing company has to test every single device before it is made available to hospital staff. This is why Innovative Health’s complaint rates are so low. See our video about how Innovative Health’s quality system permeates everything we do:

01/07/2025

At Innovative Health, we rely on standards to be able to legally market products, to effectively run the production process, to determine cleanliness, to assess functionality, and to ensure the safe and effective operations of our facilities. See our video about how Innovative Health’s quality system permeates everything we do:

24/06/2025

Since Innovative Health is a regulated medical facility, our focus on patient safety permeates everything we do. See our video about how Innovative Health’s quality system permeates everything we do:

23/06/2025

What Does AMDR Membership Mean?

AMDR, as a trade association, demands higher standards from its members than those formally imposed on the industry by regulation.

19/06/2025

At Innovative Health, the process of deciding to reprocess a certain device involves several departments and several cross-functional meetings before the paperwork for FDA is prepared. Much more is involved, including a comprehensive risk assessment, assessment of feasibility, looking at the cleaning process, determining how to test and inspect the device, and development of validation techniques and methods. See our video about how Innovative Health works to get FDA clearances:

12/06/2025

Before Innovative Health applies for a clearance to reprocess a device, a submission has to be prepared. This is a very extensive document that essentially explains how Innovative Health plans to go about reprocessing the device, and how this can be done safely by ensuring that the reprocessed device is substantially equivalent to a new device. See our video about how Innovative Health works to get FDA clearances:

05/06/2025

Before we start working on a clearance from FDA to reprocess single-use devices, Innovative Health’s quality department looks at the device features and designs to determine that materials or functionality don’t degrade with more uses. See our video about how Innovative Health works to get FDA clearances:

30/05/2025

Before Innovative Health even starts working on documents to ask FDA for clearance to reprocess a single-use device, staff across a number of departments evaluate whether it should be reprocessed for another use. See our video about how Innovative Health works to get FDA clearances:

30/05/2025

Getting an FDA Clearance to Sell Reprocessed Single-Use Medical Devices

The healthcare industry needs Reviewers with high standards, uncompromised diligence, and the time to evaluate new drugs and devices thoroughly.