QA CONNECT
MANAGEMENT
CONSULTING LLC
Providing medical device and
biotechnology audits that support FDA 21
CFR 820, and ISO
(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
- Kaizen Process 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 and ISO 9001:2015) and improving quality management systems within other sectors.
Customer Satisfaction
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Services We Offer:
We offer Internal Audits, Supplier Audits, Kaizen Process Audits, FDA visit preparation (Mock Audits), and Backlog QA projects.
Internal Audits
- ISO 13485:2016 full system QMS audits
- Remote audits
Kaizen Process Audits
Short-term process audits of manufacturing assembly lines for Class III devices (stents and catheters)
Supplier Audits
Audits of vendors and suppliers to assess qualifications as a approved suppliers.
Setting up Quality Systems
Helping medical device start-ups and smaller biotechnology companies setup and implement an entry-level or full-scale QMS based on client and customer outputs.
FDA Visit Preparation
Preparing clients such as medical device and biotech companies for anticipated FDA visits. Mock audits, protocol, and documentation preparation.
Backlog QA Projects
Complaints. Recalls, CAPA’s, Audit responses, and MDR processing for Class II and Class III clients.
Blog Posts
“The transformation will come from leadership.”
W. Edwards Deming