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
In Vitro Diagnostics (IVDs)
Regulatory, Quality, Clinical, and
Program Management -
Integrated Solutions.
Regulatory Affairs
We lead and support regulatory projects covering IDE, 510(k), de novo 510(k), and PMA from end to end.
Quality Assurance
Implementing efficient and cost-effective quality systems based on QMSR, ISO 13485, CAP/CLIA.
LDT - CLIA/CAP
Extensive experience in iCLIA/CAP based LDTs to meet the FDA and IVDR requirement.
EU IVDR
AltaQ team has implemented strategies to successfully meet EU requirements for CE marking.
FDA QMSR
ISO 13485
AltaQ has expertise in integrating FDA QMSR and ISO 13485.
Validations
We help in developing and executing Analytical, Software, and Process, and Facility Validations
Software QA
We have extensive experience in developing software documentation covering for FDA submissions.
Clinical Affairs
We develop and executes 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
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The FDA LDT Final Rule and SCOTUS ruling on the Chevron Doctrine - What is next?
The FDA's LDT Rule Explained
