The Operational Excellence Academy
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ISO 13485 QUALITY MANAGEMENT SYSTEM

Our Mission

Our mission is to build quality systems that not only meet regulatory standards but also strengthen organizational performance, innovation, and customer trust. years of experience and a deep knowledge of their subjects, they provide a top-notch education to every student.

At The Operational Excellence Academy

We specialize in guiding medical device manufacturers through every stage of ISO 13485:2016 Quality Management System (QMS) development and eQMS implementation.


Our expert team partners with emerging and established medical device organizations to design and deploy end-to-end QMS roadmaps aligned with FDA 21 CFR Part 820 and global regulatory expectations.

Our Offering

  • QMS Documentation Development – SOPs, Forms, Records, and Templates tailored to your processes.
  •  Quality System Implementation Roadmaps – clear, phased approaches for design, production, and post-market compliance.
  • Compliance Training & Workshops – empowering teams to meet ISO 13485, MDR, and FDA requirements confidently.
  • Audit Readiness & Continuous Improvement Coaching – ensuring your organization maintains a state of compliance and excellence.

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ISO 13485- Deploy eQMS

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ISO Audit Preparation

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Material, Training & Coaching

Certification Training & Coaching to solve!

The Operational Excellence Academy

Self learn - Fundamentals of IQ OQ PQ Process Validation

When you understand IQ/OQ/PQ deeply, you can:

- Plan validation efficiently (reduce rework and delays)

- Execute protocols with confidence

- Write strong validation documentation (IQ/OQ/PQ protocols and reports)

- Reduce FDA inspection risk (fewer 483 observations)

- Build a validation approach aligned with ISO 13485 and FD

Purchase the course

For all your other Business needs

Fill out the CONTACT US form with all the details

CLICK HERE

Welcome to The Operational Excellence Academy!

Welcome to The Operational Excellence Academy!

Welcome to The Operational Excellence Academy!

Welcome to The Operational Excellence Academy!

Welcome to The Operational Excellence Academy!

Welcome to The Operational Excellence Academy!

  • Home
  • LeanSixSigma
  • ISO 13485 Services
  • Process Validation
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