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Burt and Associates
Who We Are
Our Team
Core Values
Global Citizenship
Connecting
Diversity & Inclusion
What We Do
All Services
Quality & Regulatory
Operations & Engineering
Staffing & Recruiting
SaMD / SiMD
Start-up Partnership
Audit Support
News & Events
Careers
Connect
Folder: Who We Are
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Our Team
Core Values
Global Citizenship
Connecting
Diversity & Inclusion
Folder: What We Do
Back
All Services
Quality & Regulatory
Operations & Engineering
Staffing & Recruiting
SaMD / SiMD
Start-up Partnership
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The Power of Focus: Harnessing The 80/20 Principle For Breakthrough Success
Book Summary & Review Monica Burt 4/11/24 Book Summary & Review Monica Burt 4/11/24

The Power of Focus: Harnessing The 80/20 Principle For Breakthrough Success

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The CMO to CDMO Leap: Is There Another Path? 
Industry Insight Monica Burt 4/9/24 Industry Insight Monica Burt 4/9/24

The CMO to CDMO Leap: Is There Another Path? 

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The Cruciality of Contamination Control in ISO 13485:2016 for Medical Device Manufacturers
Quality Assurance Monica Burt 3/27/24 Quality Assurance Monica Burt 3/27/24

The Cruciality of Contamination Control in ISO 13485:2016 for Medical Device Manufacturers

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Periodic Safety Update Reports: Another document to manage for medical device manufacturers…
Regulatory Compliance and Guidance Esra Barut 1/29/24 Regulatory Compliance and Guidance Esra Barut 1/29/24

Periodic Safety Update Reports: Another document to manage for medical device manufacturers…

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Proven Ways to Hold Supply Chain Partners Accountable for Quality and Transparency
Relevant Materials Monica Burt 6/16/23 Relevant Materials Monica Burt 6/16/23

Proven Ways to Hold Supply Chain Partners Accountable for Quality and Transparency

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CALL TO ACTION: Trade Skill Shortage and How to Overcome the Challenge
Relevant Materials Monica Burt 6/14/23 Relevant Materials Monica Burt 6/14/23

CALL TO ACTION: Trade Skill Shortage and How to Overcome the Challenge

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Join MB&A at OMTEC Expo 2023
Events Monica Burt 6/5/23 Events Monica Burt 6/5/23

Join MB&A at OMTEC Expo 2023

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The Case For MDR Extension
Regulatory News Amanda Rudd, PhD 2/13/23 Regulatory News Amanda Rudd, PhD 2/13/23

The Case For MDR Extension

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MB&A Ribbon Cutting Ceremony
Events Monica Burt 2/1/23 Events Monica Burt 2/1/23

MB&A Ribbon Cutting Ceremony

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The UK’s Outlook On AIaMD And Need For Regulatory Improvements
Industry News Amanda Rudd, PhD 1/27/23 Industry News Amanda Rudd, PhD 1/27/23

The UK’s Outlook On AIaMD And Need For Regulatory Improvements

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Switzerland to Accept FDA Approved Medical Devices
Industry News Amanda Rudd, PhD 12/13/22 Industry News Amanda Rudd, PhD 12/13/22

Switzerland to Accept FDA Approved Medical Devices

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Foundational Tools for Your Next AI/ML Technology
Relevant Materials Monica Burt 6/23/22 Relevant Materials Monica Burt 6/23/22

Foundational Tools for Your Next AI/ML Technology

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How Will FDA’s CDRH Reorganization Impact Me?
Industry News Monica Burt 2/15/22 Industry News Monica Burt 2/15/22

How Will FDA’s CDRH Reorganization Impact Me?

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2022 OMTEC Conference
Events Monica Burt 2/8/22 Events Monica Burt 2/8/22

2022 OMTEC Conference

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SaMD Best Practices Orthopedic Companies Need to Follow for Success
Industry News Monica Burt 2/8/22 Industry News Monica Burt 2/8/22

SaMD Best Practices Orthopedic Companies Need to Follow for Success

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Monica Burt & Associates, LLC

2156 Johnson Rd
Germantown, TN 38139

Call today at 1-800-253-6121

Who We Are

Our Team

Guiding Principles

Global Citizenship

Connecting

Diversity & Inclusion

What We Do

Quality & Regulatory

Operations & Engineering

Staffing & Recruiting

SaMD / SiMD

Start-up Partnership

Audit Support

All Services

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