Quality and Regulatory

Ensuring Safety through Process

Quality Policy: Quality Without Boundries

AirStrip is committed to ensuring:

  • Continuous evaluation and improvement to the quality system, product and processes to promote     effectiveness of the Quality Management System
  • Effectiveness in delivering quality healthcare products
  • Compliance with Regulatory and Process requirements
  • Creativity, innovation excellence in all we do
  • Practical and agile strategies to develop the best possible products that meet customer requirements, reduce risk, and help clinicians do their jobs

AirStrip has received regulatory clearance to market AirStrip ONE® in the European Community (CE mark 2797), Canada, Australia, and Japan. Other markets would require regulatory clearance prior to shipment and installation of AirStrip ONE. The level of clearance required for AirStrip ONE depends on the local jurisdiction, the networked medical device and the output mobile device used. Cellular, Wi-Fi, or another Internet connection is required.

Cybersecurity Controls

As more medical devices become networked, and more data is collected, the opportunity for data loss, data breach, or data corruption has increased exponentially. Data loss, particularly in medical environments, can cause significant harm to our customers, and ultimately to AirStrip’s reputation, as HIPAA requirements or GDPR requirements are violated. To ensure that information in the AirStrip network and in the customer implementation of its software is secure, AirStrip has been certified to ISO 27001:2013. The certification assures that security is a key element in AirStrip's processes. This standard is designed to manage information securely using controls that assure information available to those who are authorized; while ensuring it remains confidential; and that the integrity of the information is secure in order to meet AirStrip’s legal, regulatory, contractual, and business requirements.

The Information Security Policy is “security vigilant” and requires that AirStrip Technologies Inc. comply with the requirements of ISO 27001 to ensure the protection of all information entrusted to it as a result of operations, its interface with clients, employees, and contractors, and the work product it creates. AirStrip’s cybersecurity is focused on protecting one of AirStrip’s most valuable assets: information. Information security requires controls to ensure confidentiality and that information is available only to those with proper credentials to maintain the integrity of all data in use or archived. AirStrip regularly evaluates and continually improves its cybersecurity controls to provide necessary security controls while maximizing information confidentiality, availability, and integrity for all parties who are authorized to access and use it. Should you have questions about the security of AirStrip products please contact security@airstrip.com.

Corporate Governance

Use of Information and Intent and Purpose

The information on this site is intended for customers, partners, and healthcare professionals using or considering AirStrip Technology Inc. products and services. All information, including Prescribing Information for our products, abides by the laws, regulatory requirements, and medical practices for the United States may not be appropriate for use outside of the United States, unless regulatory releases have been obtained.

Content © 2014-2023. AirStrip®. All rights reserved.

Trademarks not belonging to AirStrip Technologies are the property of their respective companies. iPhone® and iPad® are registered trademarks of Apple Inc., Android is a trademark of Google LLC.

Forward-Looking Statements

Information on the site, other than historical information, may consist of forward-looking statements that involve risks and uncertainties. These statements may differ materially from actual future events or results. For instance, factors which could cause results to differ from future events include the rate of adoption of new products, competitive pricing actions, and marketing programs, among others.

No Warranty

This website represents the most current information available as of the date of publication. All warranties for the product are contained in the licensing agreements, and this site makes no changes to those warranties.

For more information about our Regulatory and Compliance initiatives contact us at qara@airstrip.com.

Regulatory Documents

We are sure we can help you

Get in touch with us to schedule a demo today.