Quality Policy

iRhythm Technologies, Inc. is a responsive provider of innovative healthcare information services for continuous ambulatory cardiac monitoring that meet or exceed the quality expectations of our customers and industry.

Our commitment

  • Continuously improving our quality management system
  • Comply with all applicable regulatory requirements, and
  • Deliver excellence to customers through our products, processes, service and data.

Quality means a lot of things to different people. We defined the optimum level of quality as one that reliably meets or exceeds the expectations of customers and regulators while maximizing competitive advantage and shareholder value.


Quality Management System

iRhythm Technologies, Inc. is a ISO 13485 certified company.


Quality Management System

The joint commission

iRhythm Technologies, Inc. has earned The Joint Commission’s Gold Seal of Approval® for Ambulatory Health Care Accreditation by demonstrating continuous compliance with its nationally recognized standards. The Gold Seal of Approval® is a symbol of quality that reflects an organization’s commitment to providing safe and effective patient care.


  • The joint commission
  • The joint commission

Independent Diagnostic Testing Facility (IDTF)

iRhythm's sophisticated IT infrastructure and systems are designed to help physicians and their staff provide care for their patients, including:

  • Multiple options for enrolling patients: web or phone
  • Notifications based on individual account-specific criteria
  • Simple, intuitive patient reports
  • Device training for patients and staff
  • A paperless patient reporting system.

All diagnostic data collected by the Zio monitor are analyzed by Certified Cardiographic Technicians at the iRhythm Clinical Centers (iCC), Independent Diagnostic Testing Facilities (IDTF). The iCC are staffed 24/7 and offer translation services in more than 170 languages. As IDTF, the iCC adhere to Medicare Independent Diagnostic Performance Standards. These standards (42 C.F.R. section 410.33) can be found in their entirety at the Centers for Medicare & Medicaid Services website.

 

FIPS 140-2 VALIDATION

Zio by iRhythm has received the National Institute of Standards and Technology’s (NIST) Federal Information Processing Standard (FIPS) 140-2 validation. While currently meeting all commercial requirements for data encryption, the FIPS validation achieves an added level of security required by specific government healthcare agencies. This effort further demonstrates iRhythm’s continued commitment to patient privacy and data security.

iRhythm’s security validation is available on the NIST website, certificate number #3118.

Independent Diagnostic Testing Facility

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