Medical Device QA/RA Consulting Services

ABOUT US

At MDR Consultants Inc, we believe in providing more than just a service to our clients. Our team of experienced consultants specialize in delivering cutting-edge training and consulting services to medical device companies looking to improve their quality management systems.

From documentation maintenance to monitoring and improvement, we offer cost-effective solutions based on proven and trusted methods. Our courses are designed to meet the needs of medical device professionals, and our team of certified trainers provides training programs that empower individuals to be successful in their field.

At MDR Consultants Inc, we are committed to delivering results and ensuring the success of your medical device products. Let us help you get there. Book a free consultation with us today.

OUR COMPANY

Our Mission

Our mission is to empower medical device companies to deliver safe and effective solutions to patients. By offering a range of consultancy services and cutting-edge training programs, we aim to raise the bar on quality, safety, and competence in the medical device industry. Our focus is always on patient safety and ensuring our clients are confident in their ability to navigate the ever-changing regulatory landscape.

Experience and Professionalism

Our team of consultants bring years of experience from within quality assurance and regulatory affairs management positions at medical device companies, as well as medical device lead auditors for notified bodies. This combination of hands-on experience and in-depth knowledge of regulatory requirements allows us to deliver efficient and effective solutions to our clients. Our team is dedicated to ensuring competence, conformance, and compliance with all regulatory and statutory requirements.

Our Services

Quality Management System

Expert Consultants in Quality Management Systems MDR Consultants strives to provide you with proven, trusted, and cost-effective solutions. We…

Internal and Vendor Audits

Internal and Vendor Audits MDR Consultants certified and qualified former Lead Medical Device auditors of Notified Bodies can provide…

Training

Courses Designed for You MDR Consultants offers you best-in-class training programs developed and presented from the unique perspective of…

Special Projects

Expert Consultants You can Trust MDR Consultants strives to provide you with proven, trusted, and cost-effective solutions. Our…

FDA Quality and Risk Management Systems

Medical Device Risk Management Consulting Services Risk management is the foundation on which our systems, processes, and products are…

Medical Device Quality ManagementSystems

Medical Devices Quality Management System Services from your Experts at MDR Consultants An effective Quality Management System that ensures…

Medical Device Consulting Services

Professional Medical Device Consulting Services MDR Consultants provides industry-leading medical device consulting services and training courses that are designed…

Our Courses

Introduction, Overview, and Implementation Process of the EU MDR (2017/745); EU MDR 101

Online Course

Duration
Self-Paced Online Course

Course Fee
$500.00

Language
English

Introduction, Overview, and Implementation Process of the EU MDR (2017/745); EU MDR 101

Advanced Application & Implementation Process of the EU MDR (2017/745); EU MDR 201

Online Course

Duration
2 Day Live Training Course

Course Fee
$2,000.00

Language
English

Advanced Application & Implementation Process of the EU MDR (2017/745); EU MDR 201

New EU MDR (European Union Medical Device Regulation) Training Course – Medical Device Note on Private Classes: Our trainers are bilingual, English and Spanish, and are able to teach any course in the language…

Our latest Blog

January 17, 2023

Medical Device Validation Requirements, Key Aspects to Remember

Author: Isabel Osorio is the president and founder of MDR Consulting
Inc.

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.

May 13, 2021

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

Your statutory & regulatory experts

Your medical device experts

ABOUT US