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.

Book A Free Consultation

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 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

MDR Consultants was founded by Isabel Osorio, a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor, a Certified Trainer for Notified Bodies, and as a Consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures. This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of MDR Consultant’s mission to provide best-in-class training and consulting services.

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