CAPABILITIES & COMPLIANCE

Dedicated to the Requirements of In Vitro Diagnostics

25,000 ft2 of Advanced Facilities

Located in the heart of Marseille Immunopôle - Luminy, near research institutions and platforms in immunology, research centers and oncology care, and numerous biotechnology companies, HalioDx has 25,000 ft2 of advanced facilities including:

  • A CLIA laboratory (2,200 ft2), allowing the company to receive US patient samples for Immunoscore® Colon testing
  • A R&D and Contract Development laboratory (11,000  ft2), ISO 13485 & ISO 9001 certified and compliant with FDA regulatory requirements and the Directive 98/79 EC
  • A manufacturing unit (8,700 ft2), ISO 13485 certified, cGMP-compliant, which has been subject to a full audit

HalioDx has all of the technology platforms necessary for its operations, including immunohistochemistry, nCounter® technology (Nanostring), digital pathology, high throughput Next Generation Sequencing and quantitative PCR.

Quality & Compliance

HalioDx is certified according to the quality standard ISO 9001 (since 2012) as well as ISO 13485 (since 2007), an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacturing of medical devices.

The Quality Management System is also maintained to meet the Medical Device Directive 98/79/EC. When necessary, products are developed, manufactured and controlled in line with the US regulation of FDA and following cGMP requirements for medical devices.

Click to download our ISO certificates.

EN ISO 9001-2008

EN ISO 13485-2012