Quality and Regulatory
Quality without Boundaries
The Quality Policy of AirStrip Technologies Inc is “Quality without Boundaries”. This policy is enacted by implementing the following Quality Values:
- Be innovative using consistent processes. Process control allows new technologies and functions to be incorporated consistently to move technology forward without interruption of additional application features. To facilitate this value, AirStrip documents its processes and manages change to keep the teams moving in the same direction toward customer satisfaction.
- Work together. Working toward common goals of both our Enterprise Customers and Users while developing new solutions and workflows to promote clinical efficiency and patient care. To facilitate this value, we use collaborative environments to assure teamwork is a high priority.
- Do the right thing. Using documented processes and consensus standard certification, we uphold the regulatory requirements established for our products while ensuring innovation, continual improvement, and promoting safety and functionality. To facilitate this value, AirStrip is certified by BSI to ISO 13485:2016 and MDSAP.
- Continually improve. Challenging ourselves and the technology we produce to be the best, and continue to improve with new features, workflows and improvements to assure the flexibility of the AirStrip ONE solution. To facilitate this value, we listen to our Users for input, engage with clinicians and programmers to look for new methods to improve clinical decision making and foster patient care and satisfaction.
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.
Commitment to Cybersecurity
As more medical devices become networked, and more data is collected to facilitate patient care, 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 Enterprise Customers, and ultimately to AirStrip’s reputation, as HIPAA requirements or GDPR requirements are violated. To assure that information in the AirStrip network and in its customer implementation of its software is secure, AirStrip is currently certifying to ISO 27001:2013. (1) This standard is designed to manage information securely using controls that assure information available to those who are authorized; that information remains confidential; and that the integrity of the information remains 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 in order to assure information security and 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 to protect one of AirStrip’s most valuable assets: information. Information security requires controls to ensure confidentiality, ensure information is available only to those with proper credentials and maintain the integrity of all data in use or archived.
In order to facilitate the implementation of this policy , AirStrip will regularly evaluate and continually improve its cybersecurity controls to provide necessary security controls while maximizing information confidentiality, availability and integrity of all parties who are authorized to access and use it.
(1) Stage 1 was successfully completed, Stage 2 is scheduled for March 2020
Use of Information
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.
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