About MDR Consultants Inc.

Former FDA reviewers and Notified Body auditors providing practical regulatory solutions since 2019. We welcome the opportunity to become your Medical Device Regulatory Consultants.

Our Regulatory Heritage

Since our founding, MDR Consultants Inc. has been dedicated to helping medical device manufacturers navigate complex global regulations.

What sets us apart is our practical approach – we don’t just interpret regulations, we show you how to implement them efficiently.

Ready to Strengthen Your Regulatory Strategy?

Partner with consultants who speak both regulator and manufacturer language.

Contact us today!

About MDR Consultants Inc.

Former FDA reviewers and Notified Body auditors providing practical regulatory solutions since 2019. We welcome the opportunity to become your Medical Device Regulatory Consultants.

Our Regulatory Heritage

Since our founding, MDR Consultants Inc. has been dedicated to helping medical device manufacturers navigate complex global regulations.

What sets us apart is our practical approach – we don’t just interpret regulations, we show you how to implement them efficiently.

Ready to Strengthen Your Regulatory Strategy?

Partner with consultants who speak both regulator and manufacturer language.

Our Mission

We empower medical device companies to deliver safe, effective solutions to patients worldwide. Through expert consultancy and innovative training programs, we elevate quality standards while simplifying regulatory compliance.

Our Core Values

  • • Regulatory Integrity: Strict adherence to compliance requirements
  • • Practical Solutions: Implementation-focused guidance
  • • Client Education: Empowering your team through training

Experience and Professionalism

Trusted regulatory partners with decades of combined experience helping medical device companies achieve and maintain compliance.

  • •
    Former FDA Reviewers & Notified Body Auditors
  • •
    Sterilization & Biomedical Specialists
  • •
    Technical Documentation Experts

We Specialize In:

FDA 21 CFR 820
ISO 13485
UK MDR
ISO 14971

Don’t leave compliance to chance. Partner with regulatory experts who speak both auditor and manufacturer language.

BOOK FREE CONSULTATION
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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.

20+
Devices Launched
500+
Audits Conducted
90%
Retention Rate

“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.

Key differentiator from typical consultants

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:

  • ✓
    End-to-End Regulatory Support:From FDA pre-submissions to EU MDR technical documentation, we cover all compliance requirements.
  • ✓
    Biomedical Engineering Expertise:Unique ability to redesign devices for compliance while maintaining functionality and safety.
  • ✓
    Official Certified Trainer:Authorized to certify your team on FDA QMSR, EU MDR, ISO 13485, and MDSAP implementation.
  • ✓
    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

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