In Vitro Diagnostics (IVDs)

Regulatory, Quality, Clinical, and

Program Management - Integrated Solutions

IVD

SERVICES

Our significant and integrated experience enables us to implement industry practices to achieve results.

We lead and support regulatory projects covering IDE, 510(k), de novo 510(k), and PMA from end to end.

Implementing efficient and cost-effective quality systems based on QMSR, ISO 13485, and CLIA/CAP

Extensive experience in CLIA/CAP-based LDTs to meet the FDA and IVDR requirements

The AltaQ team has implemented strategies to successfully meet EU requirements for CE marking.

AltaQ has expertise in integrating FDA QMSR and ISO 13485.

We help in developing and executing Analytical, Software, Process, and Facility Validations.

We have extensive experience in developing software documentation covering FDA submissions.

We develop and execute clinical validation protocols and plans for regulatory submissions.

Our team members have been serving the life sciences industry for more than 30 years.

Sep 25, 20252 min read

Aug 26, 20252 min read

Feb 5, 20252 min read