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 world 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.
After, she changed her career path and began working in an entry level position as a quality and design engineer supporting all aspects of the medical device lifecycle to include design, development, risk management, manufacturing, and vendor monitoring and control. She was lucky enough to work for a consulting firm that supported her continued learning process and that offered her dozens of projects of medical devices that required full development from idea to market release. The development of these projects also included the design and generation or review and improvement of relevant quality management systems. She was able to grow from a quality and design engineer position to being the manager of the organization’s quality and regulatory department.
After obtaining 10 years of hands-on experience in all aspects of the documentation, implementation, and maintenance of an effective Quality Management system and producing products that consistently met all applicable requirements, she was recruited by one of the worlds leading certification bodies.
This organization also supported her career development and she became a recognized lead auditor who was given the tasks of both training new hires for the organization as well as training members of industry by teaching training classes for the medical device industry on related statutory and regulatory standards and regulations to include ISO 9001, ISO 13485, ISO 14971, MDSAP (All applicable jurisdictions), EU MDD and EU MDR. She was recognized for her excellence under her new role by her employer, the industry she served, and her peers. Her position, as an industry lead auditor and training manager representing a certification body, allowed her to obtain even a deeper understanding of the relationship between a medical device organization performance, success, and longevity to the design, implementation, and effectiveness of their quality management system. A knowledge that she is eager to share with her clients. Though her career, she has met top performers in their field of expertise that have now joined her to meet the organization’s 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. Contact us today and let’s find out how we can help you and your company.
To provide consultancy services to the medical device industry that are compliant and conformant to all applicable standards and regulations in order to obtain tangible improvements of the related Quality Management System (QMS) and its ability to produce products that meet all relevant requirements.
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.
With decades of experience, our MDR Consultants have the knowledge and hands-on experience necessary to help your organization assess, implement, monitor, and maintain and effective and lean quality management system that is in compliance and conformance with medical device industry specific national and international applicable statutory and regulatory requirements.
Our Consultancy services cover the following medical device industry criteria: ISO 9001, ISO 13485, ISO 14971, MDSAP (Australia TG (MD) R & TG Act, Brazil Federal Law and RDC ANVISA, Canada (MDR) SOR/98-282 Part 1, Japan MHLW MO169 & PMD Act, US FDA 21 CFR 820), EU MDD and EU MDR.