KMDGlobalConsulting.com
KMDGlobalConsulting.com
Your MedTech
Partner in Regulatory Compliance
Your MedTech
Partner in Regulatory Compliance
Equip your team with the knowledge
and tools they need to succeed.
Equip your team with the knowledge
and tools they need to succeed.
Over 200+ Five Star Reviews
Optimize and Enhance Your Business
From Regulatory Risks
Optimize and Enhance Your Business From Regulatory Risks
%
Companies face challenges in maintaining compliance with evolving regulations.
%
Companies face challenges in maintaining compliance with evolving regulations.
%
85
Companies face challenges in maintaining compliance with evolving regulations.
M
Non-compliance costs companies an average of $10 million annually in penalties.
M
Non-compliance costs companies an average of $10 million annually in penalties.
M
10
Non-compliance costs companies an average of $10 million annually in penalties.
%
Effective training programs can reduce compliance violations by up to 75%.
%
Effective training programs can reduce compliance violations by up to 75%.
%
90
Effective training programs can reduce compliance violations by up to 75%.
Here is how we grow together.
Hi, I’m Katie Dale, founder of KMD Consulting.
I started this company because I saw too many businesses struggling with the same thing: the overwhelming complexity of MedTech regulations.
Our mission is clear: to provide tailored, proactive solutions that turn compliance hurdles into opportunities for growth.
Services
Services
Our Services
Our Services
Quality-Centric, Global Expertise
Quality-Centric, Global Expertise
For MedTech.
For MedTech.
Expert Guidance for Regulatory Challenges
A Complete Strategic Advisory
Your roadmap to compliance confidence
We provide tailored regulatory strategies that align with your business goals, helping your Enterprise:
✔ Navigate complex FDA/EU requirements.
✔ Proactively address compliance gaps.
✔ Make informed decisions with regulatory assessments.
✔ Prepare for future industry changes.
A Complete Strategic Advisory
Your roadmap to compliance confidence
We provide tailored regulatory strategies that align with your business goals, helping your Enterprise:
✔ Navigate complex FDA/EU requirements.
✔ Proactively address compliance gaps.
✔ Make informed decisions with regulatory assessments.
✔ Prepare for future industry changes.
1
Audits
Audits can be stressful and time-consuming, especially when you’re unsure if your systems and documentation meet regulatory standards.
When you’re unsure if your systems and documentation meet regulatory standards.
2
Training & Expertise
Our customized training programs empower your team with the skills and knowledge they need to maintain compliance and operate efficiently. We turn your team into regulatory experts.
We turn your team into regulatory experts.
3
Navigating Complex Regulations
Pharmaceutical regulations are constantly evolving, making it difficult to stay compliant while focusing on your core business.
Pharmaceutical regulations are constantly evolving, making it difficult to stay compliant.
4
System Optimizations
Inefficient systems can slow down operations, increase costs, and create compliance risks.
5
Technical Reviews
In the intricate landscape of medical devices and development, the accuracy and robustness of your technical data, processes, and strategies are paramount. Our Technical Review service offers an independent, meticulous assessment designed to fortify your projects against potential setbacks.
6
Documentation
In the medical device and pharmaceutical sectors, documentation is not merely an administrative task; it is a critical component of your quality system and a direct reflection of your commitment to regulatory compliance and operational integrity. Comprehensive, accurate, and accessible documentation is essential for day-to-day operations, regulatory submissions, and inspection preparedness.
7
Requirements
Clear, comprehensive, and compliant requirements are the bedrock of any successful project or system in the regulated life sciences industry. Misaligned or incomplete requirements can lead to significant delays, budget overruns, and solutions that fail to meet critical user needs or regulatory mandates.
Client Stories
Hear from our Clients.
Stories
straight
from
the
people
we
helped!
"
“KMD working with our team feels like having a secret weapon. ”
"
“KMD working with our team feels like having a secret weapon. ”
"
“I came in with high hopes, and they absolutely blew me away. From strategy to execution, every detail was on point. I’m telling everyone I know - hire them!”
"
“I came in with high hopes, and they absolutely blew me away. From strategy to execution, every detail was on point. I’m telling everyone I know - hire them!”
"
“Our Organization went from a whisper to a roar.”
"
“Our Organization went from a whisper to a roar.”
Process
Why Partnering With Us Is The Smartest Move!
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Client Stories
Client Stories
Why Partnering With Us
Is The Smartest Move!
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Our post-market surveillance services help you meet regulatory requirements and protect your brand’s reputation.
We ensure your documentation meets regulatory standards. Our expertise helps you maintain accurate, up-to-date records for audits and inspections.
Our technical reviews and gap analysis keep your operations running smoothly and compliant.
We prepare and review submissions to ensure accuracy, completeness, and timely approval.
Knowledge is power. We provide training programs that equip your team with the skills to navigate compliance.
Benefits to Expect
Measureable & Impactful Results
Benefits to Expect
Measureable & Impactful Results
Before Services ❌
Non-Compliant : Struggling to meet regulatory standards.
Non-Compliant : Struggling to meet regulatory standards.
Disorganized processes and documentation
Disorganized processes and documentation
Wasted time and resources due to inefficiencies.
Wasted time and resources due to inefficiencies.
Overwhelmed by regulatory complexity.
Overwhelmed by regulatory complexity.
Reactive: Constantly putting out fires.
Reactive: Constantly putting out fires.
Costly: High costs due to inefficiencies and penalties.
Costly: High costs due to inefficiencies and penalties.
Disconnected systems and processes.
Disconnected systems and processes.
Quick fixes that don’t solve underlying issues.
Quick fixes that don’t solve underlying issues.
Just Another Client
Just Another Client
With
KMD Consulting ✅
Fully Compliant: Fully aligned with all regulatory requirements.
Fully Compliant: Fully aligned with all regulatory requirements.
Clear, structured systems and workflows.
Clear, structured systems and workflows.
Streamlined operations and improved productivity.
Streamlined operations and improved productivity.
Empowered with knowledge and tools to succeed.
Empowered with knowledge and tools to succeed.
Proactive: Addressing issues before they arise.
Proactive: Addressing issues before they arise.
Cost-Effective: Reduced costs through optimized processes.
Cost-Effective: Reduced costs through optimized processes.
Integrated, streamlined operations.
Integrated, streamlined operations.
Sustainable solutions that drive long-term growth.
Sustainable solutions that drive long-term growth.
Passion & Care
Passion & Care
New Articles
Documentation that Works for You: Streamlining for Efficiency and Inspection-Readiness
May 18, 2025
Proactive Strategies for Robust Regulatory Compliance & Risk Mitigation
May 10, 2025
The Blueprint for Success: Why Clearly Vetted Requirements are Non-Negotiable in Pharma & Med Device Projects
May 18, 2025
Book An Appointment Today
Schedule Today
Schedule Today
Our training programs and resources ensure your staff is confident and capable.
Book An Appointment Today
Schedule Today
We equip your team with the tools and knowledge to succeed. Our training programs and resources ensure your staff is confident and capable.
In a crowded industry, we stand out by offering more than just compliance, we deliver clarity.
In a crowded industry, we stand out by offering more than just compliance, we deliver clarity.