Quality & Compliance

Compliance & Certifications

At SHOEBOX, 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

  • SHOEBOX is ISO 27001 and HDS (France) certified by BSI under certificate numbers IS747476, HDS803603, 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 products and services.
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  • As part of our commitment to product excellence, regulatory compliance and customer satisfaction, SHOEBOX maintains a Medical Device Quality Management System (QMS) certified to ISO 13485 and MDSAP by UL.
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Audiometry Standard Compliance

SHOEBOX PureTest complies with the following standards:

  • ANSI/ASA S3.6-2025 and IEC 60645-1:2017, Type 4 Audiometer
  • Algorithms comply with ISO 8253:2010 Part 1: Pure-tone air conduction audiometry
  • Calibrations comply with ANSI/ASA S3.6-2018 and IEC 60645-1:2017

Regulatory Compliance and Registrations

  • SHOEBOX PureTest is a class II medical device listed with FDA.
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  • SHOEBOX PureTest is a class II medical device registered with Health Canada.
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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.