Enroll in our EU MDR or FDA QMSR coursesβtaught by ex-auditors.
Use our checklists to self-assess against regulations.
Hire our Ex-Notified Body Auditors for mock inspections.
We decode EU MDR, FDA QMSR, and ISO standards into actionable steps for your team.
Mock audits that reveal gaps before inspectors arrive.
Stay ahead of changes to EU MDR, FDA QMSR, and other regulations.
Streamlined documentation processes to accelerate market access.
Tailored regulatory consulting and audit services to guide your medical device company from compliance gaps to market success.
We assemble experienced medical device regulatory consultants from our collective of 20+ specialists, tailoring each team to match your exact needs.
Our network of medical device regulatory consultants ensures you get the right expertise every time.
Who know exactly what inspectors look for
With insider submission knowledge
For country-specific compliance
Isabel Osorio, Founder of MDR Consultants Inc.
“After conducting 500+ audits as a Notified Body lead Auditor, I founded this firm to give companies what they truly need: actionable compliance strategies that prevent findings before they happen.”
Supported by a dedicated team of quality and regulatory professionals who bring decades of combined experience in medical device compliance.
“Reduced technical documentation gaps by 80% in 3 months.”
β Medical Device Startup
“Cleared all FDA findings within 6 weeks.”
β Established Manufacturer
“Achieved certification with zero major findings.”
β Global MedTech Company
Contact MDR Consultants Inc. today for a personalized consultation tailored to your medical device compliance needs.
Download our expert-written guide to learn when changes to your medical device require regulatory notification under FDA, EU MDR, and Economic Operator requirements.
