Compliance & Certifications

At SHOEBOX Ltd., we prioritize compliance with industry standards, holding BSI-accredited certifications affirming our commitment to information security, quality management, and regulatory adherence. This dedication ensures the delivery of high-quality products and services in strict alignment with industry standards and regulations.

Information Security & Privacy

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    SHOEBOX Ltd. has achieved ISO/IEC 27001 certification, validated by the British Standard Institute (BSI), showcasing our proactive approach to securing information assets and aligning with industry best practices.

    For more details on our ISMS, security, and privacy posture, refer to our security policy and legal documents pages.
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    SHOEBOX enables our customers to comply with their obligations under GDPR, HIPAA, PIPEDA, and other privacy regulations as those obligations relate to the customer’s use of SHOEBOX Audiometry.
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    Our ISO 13485 Medical Device Quality Management System (QMS), audited by the British Standard Institute (BSI), ensures our dedication to product excellence, regulatory compliance, and unwavering customer satisfaction.
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Audiometry Standard Compliance

SHOEBOX Audiometry products comply with the following standards:

  • ANSI/ASA S3.6-2018 and IEC 60645-1:2017, Type 3 Audiometer
  • Algorithms comply with ISO 8253:2010 Part 1: Pure-tone air and bone conduction audiometry
  • Calibrations comply with ANSI/ASA S3.6-2018 and IEC 60645-1:2017

Regulatory Compliance and Registrations

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    SHOEBOX Audiometry is a class II medical device registered with FDA (listing number D217697).
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    SHOEBOX Audiometry is a class II medical device registered with Health Canada. __________________________________________________________________________________

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    SHOEBOX Audiometry software is a class IIa medical device registered in the EU. CE Certificate No: 661659

    CE marked Class IIa in Europe under the Medical Device Directive (98/42/EEC), notified body BSI Netherlands (2797)
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  • SHOEBOX Audiometry is listed as a Class IIa medical device with Australian TGA and New Zealand WAND
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    OSHA, MSHA: SHOEBOX enables employers to comply with their obligations under OSHA and MSHA requirements as required by 21 CFR part 1910.95  as those obligations relate to the customer’s use of SHOEBOX Audiometry Download our 1910.95 summary here.

    FRA, CSA: SHOEBOX enables customers to comply with their obligations under FRA, CSA, and other local regulations as part of their hearing conservation programs as those obligations relate to the customer’s use of SHOEBOX Audiometry.