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. Schedule a chat today for solutions without obligations.

Contact us today!

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. Schedule a chat today for solutions without obligations.

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

At MDR Consultants, we are your trusted partners in achieving regulatory compliance in the medical device industry. With a team of experts who bring a wealth of experience and knowledge, we offer a comprehensive range of services designed to help you succeed
Our consultants are a diverse group of experts, with years of experience working as medical device lead auditors, certified trainers, engineers, and former industry members.
This wealth of expertise allows us to offer you the highest level of service and expertise, helping you stay up-to-date with statutory and regulatory changes.
We specialize in assessment, evaluation, documentation, and implementation of the most efficient and effective ways to ensure competence, conformance, and compliance to regulatory and statutory requirements. Our team’s hands-on experience and extensive project management skills, combined with deep understanding of industry-specific standards and regulations, sets us apart as a leader in regulatory training and consulting services.
Whether you’re seeking certification against ISO 9001, ISO 13485, ISO 14971, UKMDR, MDSAP, Brazil Federal Law, Canada MDR, Japan MHLW, US FDA 21 CFR 820, UK MDR, EU MDD, or EU MDR, our certified consultants have the knowledge and expertise to help you create a quality management system that meets or exceeds industry standards.
Don’t leave your medical device compliance to chance. Partner with the experts at MDR Consultants and put your trust in our professionalism and experience.

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Meet the Owner

Isabel Osorio is the visionary founder of MDR Consultants, a leading authority in the medical device industry. With over two decades of dedicated experience, Isabel has been instrumental in developing more than 20 groundbreaking medical devices, guiding them from conceptualization to successful market release. Her unwavering commitment to excellence and regulatory compliance has earned her a reputation as a trusted leader in the field.

Throughout her illustrious career, Isabel has honed her expertise across various domains, including engineering, auditing, and consultancy. As a seasoned professional, she has served as a lead auditor for notified bodies, meticulously ensuring compliance with stringent regulatory requirements. For the past five years, Isabel has leveraged her vast knowledge and experience to provide invaluable consultancy services, offering strategic guidance and practical solutions to companies navigating the complex landscape of regulatory affairs.

At MDR Consultants, Isabel’s mission is clear: to empower companies and professionals to navigate regulatory challenges with confidence. Her comprehensive approach focuses on delivering tailored solutions that address the unique needs of each client, ensuring regulatory compliance and product excellence every step of the way. Through personalized training and consulting services, Isabel equips her clients with the knowledge and expertise needed to thrive in a dynamic and highly regulated environment.

As a passionate advocate for patient safety, Isabel understands the critical importance of adhering to regulatory standards and best practices. Her dedication to this cause is evident in every aspect of her work, from guiding product development processes to providing expert insights on compliance matters.

With Isabel at the helm, MDR Consultants stands as a beacon of excellence in the medical device industry. Whether you’re a seasoned industry professional or a newcomer to the field, Isabel is committed to supporting you on your journey to regulatory compliance and product excellence. Get to know Isabel and discover how she can help you achieve your goals in the ever-evolving world of medical device regulation and innovation.

Customer Feedback

Krystal and I really enjoyed your course today. We will make sure to answer the survey once it's received. Thank you for your time.

Jasmin

We appreciate the information. It sure gives us a clear picture of addressing the complexities of the new regulatory environment under EU MDR. Thank you

Chris

I appreciate all your help these past few weeks. It’s been a great help in preparing us for the audit this week.

Noemi