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Compliance &
Data Security

Regulatory compliance

Aarca Research' product IHRA is cleared for usage by the Central Drugs Standard Control Organisation (CDSCO), India's national regulatory body for pharmaceuticals and medical devices.

Medical device software compliance

Aarca Research is ISO 9001:2015 and ISO 13485:2016 certified. We follow industry-standard medical device quality management systems for procedures and processes, covering all aspects of design and development, supplier management, risk management, complaint handling, clinical data, data security, distribution, product labelling, and more.

Security and HIPAA

Data security is one of our highest priorities. Aarca Research is ISO/IEC 27001: 2013 certified and maintains HIPPA compliant policies, procedures, and technical safeguards for patient and customer data.

Secure Facilities (SOC 2)

Aarca Research is Service Organization Control 2 (SOC 2) certified to keep the health system and patient data safe.

Encryption and Backups

Aarca Research uses HIPAA-compliant and NIST recommended 256 bit AES encryption using managed keys for patient data. We conduct periodic backups and test our backups regularly to ensure data recoverability.

BAA Agreements

Aarca Research maintains BAA agreements with sub-contractors and our hosting providers to ensure HIPAA compliance.

Compliance and Security Contact

To report any security or compliance issues or concerns, please contact security@aarcaresearch.com.

Would You Like To Use IHRA
To Offer Risk Assessment Onsite?

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