Integrated Business & Healthcare Operations
Quality

Quality & Certifications

Our licences, certification status and approach to quality and information security.

Licences, Quality & Information Security

Our licences and certification status.

We hold Health Canada establishment licences and provide quality and compliance support. The information below explains our licences, information-security certification and quality management work.

Health Canada

Drug Establishment Licence (DEL)

INNOVARXI holds a Drug Establishment Licence issued by Health Canada. Contact our team to discuss the licensed activities relevant to your product and program.

Drug Establishment Services →
Health Canada

Medical Device Establishment Licence (MDEL)

INNOVARXI holds a Medical Device Establishment Licence issued by Health Canada. Our team can discuss the licence scope and how it relates to your medical device program.

Medical Device Establishment Services →
Information Security

ISO/IEC 27001:2022

INNOVARXI’s public certificate covers the Information Security Management System supporting its Data Analysis services, including Microsoft Azure-hosted infrastructure and specified supporting departments.

View certificate →
Medical Device Quality Management

ISO 13485

Certification in progress

INNOVARXI is working toward ISO 13485 certification, with a focus on strengthening its quality management processes and supporting documentation. Certification has not yet been awarded.

Discuss our quality program →

Tell us what you need help with.

Whether you have a project in mind or need ongoing support, we can talk through the work and where we can help.

Contact INNOVARXI →