Quality & Regulatory Solutions

Innovative capabilities in assay development, regulatory strategy, clinical trials and regulatory submissions.

All assay validation is performed under our certified Quality Management System (QMS) compliant to the newly published FDA Quality Management System Regulations and a Product Development Process (PDP) to ensure the highest standards of quality and assay performance are met for your specific testing necessities, applications, and requirements.

We specialize in translating groundbreaking diagnostic technologies from the laboratory to the market, following our rigorous PDP with robust design controls, ensuring that your innovations reach those in need. The Biodesix Quality and Regulatory teams leverage decades of experience to customize high-quality solutions and identify fit-for-purpose regulatory strategies for your project needs. We have experience interacting and engaging with multiple global regulators, establishing international listings and registrations, developing the most efficient and cost-effective regulatory route to obtain approval, and maintaining compliance with post-market requirements.

Biodesix QMS infrastructure is highly certified in local, US governmental and international standards and regulations and scalable to support global expansion as evidenced by multiple CE marked products under the In Vitro Diagnostic Regulation (IVDR) and international registrations and commercial markets.

CAP-accredited

CLIA-certified

NYS CLEP-approved

ISO 13485-certified

2 EU IVDR CE marked medical devices

FDA CGMP manufacturing facility

• Laboratory Developed Tests (LDT), In-Vitro Diagnostics (IVD), Companion Diagnostics (CDx), Clinical Trial Assays (CTAs), Investigational Device Exemptions (IDE), etc.
• FDA registered cGMP medical device manufacturing facility
• IVDR CE marked products on file with European authorized reps