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Our commitment to your safety

Our commitment to your safety

ISO 15189 certification

Following a conformity assessment conducted by the Bureau de normalisation du Québec in December 2022, Biron Health Group’s medical biology laboratory received accreditation for the ISO 15189 standard Medical laboratories - Requirements for quality and competence, from the Standards Council of Canada.

This accreditation replaces the Accreditation Canada standard for medical laboratories. From now on, services will be subject to a particularly demanding evaluation every year.

Certification from Accreditation Canada

Our adherence to Accreditation Canada’s high standards of excellence reflects our commitment to the quality and safety of the health care we deliver. This independent, not-for-profit accreditation organization is affiliated with the Health Standards Organization (HSO). As part of this program, our business units undergo a rigorous evaluation process every four years, managed by external peers, which has allowed them to maximize their strengths and improve their services.

  • Biron Sleep Care: “Accredited with Commendation” certification awarded in October 2018.
  • Imagix and Medvue: “Accredited with Exemplary Standing” certification awarded in February 2023. This is the highest possible distinction.

Establishment Licence from Health Canada

Biron also holds a medical device establishment licence for the importation of medical devices issued by Health Canada, which guarantees its clients access to medical devices that are approved and managed according to established procedures that comply with applicable regulatory requirements.

CLIA Certification

Our clinical laboratory, specializing in pharmacogenomic (PGx) testing, holds CLIA certification (Clinical Laboratory Improvement Amendments), confirming that our tests meet U.S. federal standards for accuracy, speed, and reliability. These rigorous standards are essential for guiding patient care decisions effectively.

While we have always adhered to CLIA standards, this official accreditation represents a significant step forward in our commitment to excellence and the quality of clinical testing.

SOC 2 Attestation

Biron holds a SOC 2 attestation following an independent audit conducted by KPMG. This attestation confirms that our internal controls meet established criteria for data security, accessibility and confidentiality. It provides our clients with assurance that their personal and clinical information is protected and handled in accordance with rigorous governance and information security standards.

CAP Accreditation

Our pathology and genetics laboratory is accredited by the College of American Pathologists (CAP), an internationally recognized benchmark for laboratory quality. This accreditation confirms that our practices comply with the highest standards of accuracy, reliability, and quality control.

TGV Certification

The TGV certification confirms that our system hosting personal information meets the applicable requirements for security, privacy protection, performance, and technology. This recognition demonstrates our strong commitment to data protection.

ISO 13485 Certification

Biron is ISO 13485 certified—an international standard for quality management systems specific to medical devices, established by the International Organization for Standardization. This certification confirms that our processes meet strict requirements for the production, management, and control of medical devices.