OUR COMPANY

Our Mission

To provide effective consultancy services to the medical device industry in order to produce results that are in compliance and conformance to all applicable standards and regulations and in order to obtain tangible improvements of the related Quality Management System (QMS) and its ability to produce products that consistently meet all relevant requirements. The safety of patients is always our main priority.

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Experience and Professionalism

With our firm, you will obtain services from experts in the assessment, evaluation, documentation, implementation, and maintenance of relevant requirements of the medical device industry. Our expertise come from years of working in QA/RA management positions in the medical device industry as well as in working in management positions, lead auditor positions, and training positions in leading notified bodies and certification organizations.

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ABOUT US

Our owner and founder, Isabel Osorio, graduated with a Bachelor’s of Science in Biomedical Engineering. Since her college years, she spent her time working in industry specific projects that applied leading technological improvements in many areas of the medical device industry to include being a member of the design team for a design for human sustainability in space; a project initiated by NASA.

After graduation, she began her career working for the third biggest medical device company in the word as a field service engineer. While working at this position, she obtained a deep understanding of the interactions, manufacturing, and design of several products that integrated fluidics, mechanical, electrical, and software components. Knowledge that proved to be an asset throughout her career.

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Our Services

Our Courses

Our latest Blog

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May 13, 2021

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

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May 03, 2021

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

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February 17, 2021

The transition period for the new EU Medical Device Regulation (MDR) is quickly approaching, is your company ready? MDR CONSULTANTS INC. can ensure you are fully prepared

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