MDR Consultants Inc.
Elite QA/RA Consulting for Medical Devices. No fluff. No guessing. Just strategy, execution, and audit-readiness that makes regulators nod in approval.
We’re a team of seasoned QA/RA experts and former notified body auditors with over 60 years of combined experience in medical device regulatory affairs, quality management, and auditing. Our focus is clear: prepare your company to pass the toughest audits — MDR, FDA, and MDSAP — with fewer nonconformities and stronger submissions.
Founded by Isabel Osorio, a biomedical engineer and veteran QA/RA strategist, MDR Consultants Inc. delivers precise, regulator-level audits and compliance strategies tailored to your unique needs. We don’t just check boxes — we dig deep to expose risks before they become findings.
Our clients range from startups launching their first device to global corporations managing complex re-certifications. Through proven methods and hands-on execution, we’ve helped companies achieve a 100% reduction in nonconformities and FDA 483 observations within the first year.
From internal audits and technical file reviews to pre-market submissions and post-market surveillance, we provide comprehensive regulatory support designed to make audits a formality — not a source of stress.
Ready to stop fearing audits and start passing them with confidence? Contact MDR Consultants Inc. today and let’s build your audit-proof strategy together.
Company Details
- Employees
- 3
- Founded
- -
- Address
- 12410 Griffing Blvd, North Miami,florida 33161,united States
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.mdrconsultants.com
- Keywords
- Medical Device Consultancy Services, Audits, EU MDR, ISO 13485:2016, ISO 14971, MDSAP, Regulatory, Quality, Risk Management, Australia TG (MD) R & TG Act, Brazil Federal Law and RDC ANVISA, Canada (MDR) SOR/98-282 Part 1, Japan MHLW MO169 & PMD Act, EU MDD, Quality Management System, QMS, Internal and Vendor Audits, Training, Gap Analysis, Medical Device, QA/RA Consultant, 2017/745, FDA CFR 820, Us FDA 21 CFR, EU MDR Training, EU MDR Course, 2017/745 Course, EU MDR Online Course, 2017/745 Online Course, Medical Device Consultant, EU MDR Consultant, 2017/745 Consultant, 510k, Design and Development, QMSR.
- HQ
- North Miami, Florida
Mdr Consultants Inc. Questions
Mdr Consultants Inc.'s website is http://www.mdrconsultants.com
Mdr Consultants Inc.'s LinkedIn profile is https://www.linkedin.com/company/mdrconsultants
Mdr Consultants Inc. has
3 employees.
View email and phone details for 3
employees at Mdr Consultants Inc..
Mdr Consultants Inc.'s industry is
Business Consulting and Services
Mdr Consultants Inc.'s top competitors are
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Mdr Consultants Inc.'s categories are Business Consulting and Services
Mdr Consultants Inc.'s founding year is 2019
