June 19, 2025
Isabel Osorio: Your Medical Device Regulatory Compliance Expert
Dual-Certified Regulatory Specialist
Isabel Osorio combines biomedical engineering with accredited certifications for Medical Device Regulatory and statutory compliance – a rare combination in RA/QA consulting.
“As a former Notified Body Lead Auditor, I help medical device companies navigate complex global regulatory compliance requirements with practical solutions.”
I don’t just point out gaps—I provide actionable compliance strategies tailored to your devices.
About MDR Consultants
We specialize in helping medical device manufacturers achieve and maintain compliance with global regulations including FDA 21 CFR, EU MDR 2017/745, MDSAP, and ISO 13485 standards through comprehensive consulting services.
Why Clients Choose My Team:
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End-to-End Regulatory Support:From FDA pre-submissions to EU MDR technical documentation, we cover all compliance requirements.
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Biomedical Engineering Expertise:Unique ability to redesign devices for compliance while maintaining functionality and safety.
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Full Product Lifecycle Experience:Developed 20+ Class I/II/III devices from concept through post-market surveillance, including complete technical documentation and clinical evaluations.
Recent client results: Reduced FDA 483 findings by 70% | Achieved EU MDR certification 3 months ahead of schedule
