QUALITY AND COMPLIANCE
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.
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
21 CFR 820 - Quality Management System Regulation
ISO 15189
ISO Standard for Clinical Laboratories - Requirements for Quality and Competence
GxP
Compliance with GMPs, GCPs, GLPs, GLPs, and GTPs
30 years
Our team members have been serving the life science industry for more than 30 years.
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