The medical device landscape continues to be characterized by exciting innovations and changing customer dynamics. Device miniaturization, robotics, image enhancement, remote monitoring, and intelligent devices with software-enabled devices transform treatment rooms and create new business models. At the same time, supplier consolidation, value-based purchasing, and increased patient empowerment force medical technology companies to rethink traditional business models.

Being one of the best MDSAP Consulting Firms, our mission is to provide consulting services to the medical device industry, which are compatible and compliant with all applicable standards and regulations, to achieve tangible improvements in the Integrated Quality Management System (QMS) and its ability to manufacture products that meet all relevant requirements. With our company, you receive the services of experts in the assessment, evaluation, documentation, implementation, and maintenance of the applicable provisions of the medical device industry.

Our experience comes from years of working in QA/RA leadership positions in the medical device industry and from leadership positions, leading auditor positions, and training positions at leading Notification Bodies and Certification Bodies. They all have passed the EU MDR Auditor Training and are professionals.

You can contact us to avail of medical device strategic consulting services. With decades of experience, knowledge, and hands-on experience necessary to help your organization assess, implement, monitor, and maintain an effective and efficient quality management system consistent with industry-specific regulatory requirements.

Our owner and founder, Isabel Osorio, has a bachelor's degree in biomedical engineering. Since his college days, he has spent time working on industry-specific projects applying cutting-edge technological improvements in many areas of the medical device industry, including as a member of the design team for sustainable space design, a project initiated by NASA.

After graduating, he started his career as a field engineer at the world's third-largest medical device company. During his tenure in this position, he gained an in-depth understanding of the interaction, production, and design of various products that integrate fluid, mechanical, electrical, and software components. Proven knowledge to be an asset throughout his career.

He then changed careers and began working in entry-level positions as a Quality and Design Engineer supporting all aspects of the medical device lifecycle, including design, development, risk management, manufacturing, and supplier monitoring and control. He is fortunate to work for a consulting firm that supports lifelong learning and offers dozens of medical device projects that require full development from idea to commercialization.