OUR COMPANY

Our Mission

Our mission is to raise the bar on quality, safety, and competence with a focus on patient safety so you feel confident in your ability to navigate the changing regulatory landscape. From consultancy services that deliver tangible improvements to the Quality Management Systems, outputs, and products offered by our clients, to cutting-edge training programs, our team has the expertise to guide you throughout every phase from design to post market activities. 

Read More

Experience and Professionalism

We understand that there are many different requirements for working in the medical device industry. That is why we have experts who specialize not only in the assessment, evaluation, and documentation against applicable requirements but also in their implementation. Our team comes from years of experience both inside QA/RA management positions at companies like yours, and as Medical Device Lead Auditors for Notified Bodies who in addition have successfully trained professionals in various roles on the most efficient and effective ways to ensure competence, conformance, and compliance to regulatory and statutory requirements.

Read More

ABOUT US

When you work with us, your company will be getting more than just a service.

We are an organization that specializes in providing cutting-edge training and consulting services for businesses looking to improve their overall efficiency through quality management systems implementation, including documentation maintenance, monitoring, and improvement.

MDR Consultants strives to provide you with proven, trusted, and cost-effective solutions. We have the expertise you need for the success of your medical device products.

BOOK A FREE CONSULTATION

Our Services

Our Courses

Our latest Blog

blog1

October 07, 2022

5 Key Aspects to Consider when Designing the Perfect Medical Device Quality Management System for your Company

Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

 

Read More
blog1

May 13, 2021

TIP # 2: ADDRESSING THE EU MDR DATE OF APPLICATION INCONSISTENCY
Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

Read More
blog1

May 03, 2021

TIP # 1: FINDING HARMONIZED STANDARDS
Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

Read More

CONTACT US