About AltaQ
Our Team
Our Expertise
Regulatory Affairs
Quality and Compliance
Software Compliance
Clinical Affairs
Validations
LDT/CLIA
QMSR/QSR
EU IVDR/MDR
Our Focus
In vitro Diagnostics
Laboratory Developed Tests
Medical Devices
Digital Health
Blogs
Let's Connect
Digital Health
Cost-effective and efficient
compliance with the LDT rule
LDT - CLIA/CAP
Extensive experience in CLIA/CAP based LDTs to meet the FDA and IVDR requirements.
Quality Assurance
Implementing efficient and cost-effective quality systems based on QMSR, ISO 13485, and CLIA/CAP.
Regulatory Affairs
We lead and support regulatory projects covering IDE, 510(k), de novo 510(k), and PMA from end to end.
FDA QMSR
ISO 13485
AltaQ has expertise in integrating the FDA's QMSR and ISO 13485.
Software QA
We have extensive experience in developing software documentation for FDA submissions.
Validations
We help in developing and executing Analytical, Software, Process, and Facility Validations
EU IVDR
The AltaQ team has implemented strategies to successfully meet EU requirements for CE marking.
Clinical Affairs
We develop and execute clinical validation protocols and plans for regulatory submissions.
Our experience is our key asset and building trust is our goal!
30 yrs
Our team members have been serving the life science industry for more than 30 years.
100%
return and retention rate
We are proud that we are able to build and trust with our clients and retain of clients for multiple years.
Recent articles
See all articles
The FDA LDT Final Rule and SCOTUS ruling on the Chevron Doctrine - What is next?
The FDA's LDT Rule Explained
