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
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Quality and Compliance
Cost-effective and integrated quality systems based on the US and international standards
AltaQ has extensive experience in developing and implementing Quality Systems based on US and international standards.
We can act as your quality system organization or support your quality department to meet organizational goals.
Let's talk
QSR/QMSR
21 CFR 820 - Quality Management System Regulation
Design Control
21 CFR 820.30: Design Control and ISO 13485:2016
QA Audits
Including QA gap analysis and mock audits, Pre-Approval Inspection (PAI) planning
ISO 62304
Medical Device Software - Software Life Cycle Processes
CLIA/CAP
Clinical Laboratory Improvement Amendments (CLIA) and CAP Compliance
ISO 13485
Medical Devices - Quality Management System
ISO 14971
Application of risk management for medical devices
eQMS
Implemented electronic Quality Management Systems
ISO 15189
ISO Standard for Clinical Laboratories - Requirements for Quality and Competence
GxP
Compliance with GMPs, GCPs, GLPs, GLPs, and GTPs
Efficient
Effective
Reliable
Efficient
Effective
Reliable
Efficient
Trust
Responsibility
Results
Trust
Responsibility
Results
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
