Industries Served

Medical Devices & In Vitro Diagnostics (IVDs)

We help medical device and IVD companies meet FDA, ISO 13485, and IVDR requirements, ensuring compliant software development, validation, and risk management for regulatory submissions.

Pharmaceutical & Biotech

We assist pharma and biotech companies in aligning software with GxP, 21 CFR Part 11, and data integrity standards, focusing on validating lab systems, clinical trial software, and regulatory compliance.

Digital Health & Software as a Medical Device (SaMD)

We guide digital health and SaMD companies through regulatory pathways, software validation, and cybersecurity, ensuring compliance with FDA, EU MDR/IVDR, and IEC 62304.

Clinical Research Organizations (CROs) & Clinical Trials

We ensure clinical trial software, ePRO, and EDC systems meet GCP and FDA standards, emphasizing validation, data integrity, and secure data transmission.

Laboratories & Biorepositories

We help labs and biorepositories validate LIMS, maintain data integrity, and comply with CLIA, CAP, and ISO 15189 for sample tracking, analysis, and reporting.

Precision Medicine

We validate bioinformatics pipelines, genomic analysis software, and digital tools, ensuring compliance with regulatory frameworks for diagnostics and therapeutics.

Companion Diagnostics (CDx)
We support CDx development with software validation, risk management, and regulatory submission strategies aligned with FDA, IVDR, and PMA requirements.

Industries Served

Companion Diagnostics (CDx) We support CDx development with software validation, risk management, and regulatory submission strategies aligned with FDA, IVDR, and PMA requirements.

Companion Diagnostics (CDx)
We support CDx development with software validation, risk management, and regulatory submission strategies aligned with FDA, IVDR, and PMA requirements.