Home Business Wire Nile Achieves ISO 13485 Certification Within Its First Year

Nile Achieves ISO 13485 Certification Within Its First Year

Becomes the only epilepsy care platform backed by a certified, medical-grade quality management system

LOS ANGELES–(BUSINESS WIRE)–Nile, an epilepsy management platform that replaces trying with knowing in epilepsy care through a patient app and provider portal, announced that it has achieved ISO 13485 Certification. The certification establishes that the processes Nile uses to design, distribute, and support its products meet the highest global standards for medical products. This accreditation makes Nile the only epilepsy care platform backed by a certified, medical-grade quality management system. The certification was issued by an accredited third-party after conducting a comprehensive, multi-day inspection of Nile’s personnel, its development process, and the epilepsy care platform.

“ISO Certification requires every department in the company to operate at the highest quality standards, and most companies need several years to attain ISO certification,” said Chris Ware, Nile’s Director of Quality. “Nile achieved certification within its first year as a company, which is an outstanding success for our team and demonstrates our commitment to delivering the highest quality solutions for the epilepsy community and our partners.”

“Nile puts the utmost importance on data integrity. Our platform is HIPAA compliant, and we use the best-in-class secure data encryption. We are FDA registered and comply with all applicable medical device regulations in the United States,” said Javad Seyedzadeh, Chief Operating Officer. “Our ISO Certification is just the next step in our commitment to compliance.”

Nile’s intuitive patient app connects patients with their care team, tracks symptoms and medications, and uses data science to support patients with their treatment plan. Nile also provides peace of mind between consultations by sharing educational content and alerting patients when seizures and side effects warrant contact.

Nile’s HCP portal shows the status of patients at-a-glance and allows physicians to support their patients in between visits. All patient-provided information can be accessed in real-time through a patient dashboard and doctors can set thresholds for which events or side effects they want to be informed about. Nile also features a medication titration manager that supports HCPs when entering complex titration schedules.

About Nile

Nile replaces trying with knowing in epilepsy care. Our mission is to enable healthcare providers to find the right treatment faster. Our digital care management platform provides tools for providers and people living with epilepsy and their caregivers to progress to data-driven, personalized care. Nile is a collaboration-driven organization and is welcoming partners in this mission. For more information, visit www.Nile.ai and email info@Nile.ai.

Contacts

For investor relations inquiries, please contact:

Artin Davidian at ir@nile.ai

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