QA CONNECT
MANAGEMENT
CONSULTING LLC
Providing medical device and
biotechnology audits that support FDA 21
CFR 820, and ISO 13485:2016
(International) regulations and other
quality services.
Why Choose Us
Trained Staff
- Certified Quality Auditors (CQA)
- Six Sigma certified
- Kaizen certified
- Validation Engineers
Backlog QA Projects
- Backlog complaints
- Audit Response Forms
- CAPA’s
- MDR/MedWatch Forms
Audits
- ISO 13485:2016 full system QMS internal audits
- Remote audits
- Supplier Audits
- ISO/IEC 17025 Calibration Audits
- Assembly Line Audits
- GLP Audits
- GMP Audits
About Us
QA Connect Management Consulting, LLC is a business that specializes in audits for the medical device sector. With a focus on Six Sigma methodologies catered to the medical device and biotechnology industry (ISO 13485: 2016, 21 CFR Part 820) and improving quality management systems within other sectors.
Services We Offer:
We offer Internal Audits, Supplier Audits, Assembly Line Audits, GLP and GMP Audits. FDA visit preparation (Mock Audits), and Backlog QA projects.
Internal Audits
- ISO 13485:2016 full system QMS audits
- Remote audits
Assembly Line, GMP, and GLP Audits
Short-term process audits of manufacturing assembly lines for Class III devices (stents and catheters) using the Kaizen method for a Kaizen event.
Supplier Audits
Setting up Quality Systems
FDA Visit Preparation
Backlog QA Projects
Blog Posts
“The transformation will come from leadership.”
W. Edwards Deming