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.

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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

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

QUESTIONS?

If you’re curious about services, we’re here to answer any questions.