Medical Device Consulting Services

dical Device Consulting Services

Gain the benefits of receiving medical device consulting services from former Notified Body auditors ensuring compliance with EU MDR, FDA QMSR, and ISO 13485 requirements.

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From Concept to Market

End-to-end guidance for medical device development and regulatory approval

Compliance Assurance

QMS implementation that meets global regulatory requirements

Audit Readiness

Preparation for Notified Body and FDA inspections

Comprehensive Medical Device Consulting

Our medical device consulting services ensure your Quality Management Systems meet all regulatory requirements while maintaining product safety. We implement solutions that achieve both compliance and business objectives.

Whether bringing a new device from concept to market or maintaining existing products, we guide companies through:

  • Design and development processes compliant with ISO 13485
  • Regulatory strategy for EU MDR, FDA QMSR, and global markets
  • Technical documentation and submission preparation
  • Post-market surveillance and vigilance requirements

Why Choose Our Consulting Services?

With decades of experience across all device classes, our former Notified Body auditors provide practical, implementation-focused guidance tailored to your specific regulatory challenges.

Ready to Accelerate Your Regulatory Success?

Schedule a free consultation with our lead consultants today.

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Expert Medical Device Consulting

MDR Consultants provides industry-leading medical device consulting to help manufacturers navigate complex global regulations. Our team of former Notified Body auditors and FDA inspection veterans offers specialized expertise in:

  • EU MDR compliance strategy
  • FDA QMSR transition
  • ISO 13485 implementation
  • Risk management systems
  • Technical documentation
  • Audit preparation

With experience across all device classes and therapeutic areas, we customize our approach to your specific product development and regulatory needs.

Medical Device Quality Management System

Medical Device Quality Management System Solutions for Compliance & Growth

At MDR Consultants, we provide expert medical device Quality Management System (QMS) solutions to help your company meet regulatory compliance and scale efficiently.

Our expert quality management system services for medical devices come from former Notified Body Auditors and are designed to scale with your organization’s quality management system and regulatory needs.

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Medical Device QMS Implementation Services

From startup to enterprise, we build compliant quality management systems aligned with ISO 13485, EU MDR, and FDA QMSR requirements.

Gap Assessment & Remediation

Identify compliance gaps and implement corrective actions before your next audit.

Audit Support & QMS Preparation

We provide audit readiness and on-site support for Notified Body and FDA inspections.

Trusted Medical Device Quality Management System Partners

An effective quality management system is the foundation for regulatory compliance and business resilience. At MDR Consultants, we specialize in developing, implementing, and optimizing QMS solutions that meet:

  • ISO 13485:2016 requirements
  • EU MDR 2017/745 compliance
  • FDA 21 CFR Part 820/QMSR Regulations
  • MDSAP country regulations

Whether you’re a startup building your first QMS or an established manufacturer transitioning to new regulations, our former Notified Body auditors provide the practical guidance you need to succeed.

Our comprehensive approach ensures your quality system grows with your business, keeping you audit-ready and compliant in an ever-evolving regulatory landscape.

Ready to Strengthen Your QMS?

Schedule a free consultation to discuss your medical device QMS strategy.

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Medical Device QMS Experts

MDR Consultants Inc. provides comprehensive medical device quality management system services for companies at all stages of growth. Our team of former Notified Body lead auditors and FDA inspection veterans helps manufacturers establish and maintain quality systems that:

  • Meet global regulatory requirements
  • Streamline compliance documentation
  • Improve audit readiness
  • Scale with business growth

Headquartered in the United States, we support global clients and have helped over 150 companies meet compliance requirements, including EU MDR, FDA QMSR, and ISO 13485.

MDR Consultants Inc. Medical Device QMS Experts

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Medical Device Regulatory Experts You Can Trust

Medical device regulatory experts with Notified Body experience providing proven, cost-effective solutions for EU MDR, FDA QMSR and ISO 13485 compliance.

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Why Choose MDR Consultants?

Our team combines decades of experience working with top Notified Bodies and leading medical device companies. This unique perspective allows us to deliver:

Regulatory Precision

Solutions tailored to your specific device classification and regulatory pathway

Cost Efficiency

Process optimizations that reduce compliance costs while improving quality

Audit-Ready Results

Systems designed to withstand Notified Body and FDA scrutiny

Comprehensive Medical Device Services

We support the entire product lifecycle with specialized expertise in:

  • ✓ Training & Education Programs
  • ✓ QMS Transition (EU MDR/MDSAP/UKMDR)
  • ✓ ISO 13485:2016 Implementation
  • ✓ Risk Management (ISO 14971:2019)
  • ✓ Compliance Gap Analysis
  • ✓ Product Design & Development
  • ✓ Quality System Procedure Development
  • ✓ Premarket Submissions (510(k), PMA)
  • ✓ Technical Documentation Management
  • ✓ Clinical Evaluation Reports
  • ✓ Post-Market Surveillance
  • ✓ Vigilance Reporting
  • ✓ Remediation Projects
  • ✓ FDA 483 Response Support

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Let’s Discuss Your Regulatory Needs

Schedule a free consultation with our Medical Device Regulatory Experts today.

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Trusted Medical Device Regulatory Consultants

MDR Consultants provides comprehensive medical device regulatory consulting services to help manufacturers navigate complex global requirements. Our team of former Notified Body lead auditors and FDA inspection veterans offers practical, implementation-focused guidance for:

  • EU MDR compliance
  • FDA QMSR transition
  • ISO 13485 certification
  • Risk management systems
  • Technical documentation
  • Audit preparation

With experience across all device classes and therapeutic areas, we customize our approach to your specific regulatory challenges. Learn more about our team.

 

Regulatory Training

Master Medical Device Regulatory Training

Master medical device regulatory training with expert-led courses for EU MDR, FDA QMSR, and ISO 13485. Developed by former Notified Body auditors, our courses bridge the gap between regulatory theory and real-world implementation.

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Certification from Real-World Experts

Enhance your professional profile with credentials valued by employers and auditors.

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Audit-Proven Training Methods

Learn compliance approaches tested in real notified body and FDA audits.

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Flexible Learning for Busy Professionals

Self-paced online courses or live sessions tailored to your schedule.

Featured Medical Device Regulatory Training Courses

EU MDR 101 – Online Course

Foundations of EU Medical Device Regulation

This EU MDR compliance training delivers a comprehensive understanding of Regulation (EU) 2017/745, taught by former Notified Body auditors.

  • Device classification & conformity assessment
  • Technical documentation requirements
  • Post-market surveillance strategies

Course Details

EU MDR 101 training course
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FDA QMSR regulation visual
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QMSR Transition – FDA Course

FDA’s New Quality System Regulation

Get your team aligned with the new FDA QMSR training and its transition to ISO 13485 compliance.

  • Clause-by-clause comparison tool
  • Gap assessment methodology
  • Inspection readiness checklist

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Trusted by Medical Device Professionals

★★★★★

“The EU MDR course gave me the confidence to lead our transition project. The practical examples were exactly what our team needed.”

– Quality Director, Orthopedic Implant Manufacturer

★★★★★

“Finally a training that explains not just what the regulations say, but how to implement them efficiently.”

– RA Specialist, Diagnostic Equipment Company

★★★★★

“The QMSR preview session saved us months of guesswork. Looking forward to the full course launch!”

– QA Manager, Cardiovascular Devices

Ready to Strengthen Your Regulatory Expertise?

Whether you’re an individual professional or need team training, we’ll help you build compliance confidence.

Medical Device Regulatory Training Resources

MDR Consultants Inc. provides medical device regulatory training for FDA QMSR, EU MDR, and ISO 13485 compliance. Developed by Notified Body lead auditors, our expert-led courses empower professionals to meet real-world compliance challenges with confidence.

Our training aligns with the EU MDR 2017/745 and FDA QMSR Final Rule. Need audit support? See our compliance checklists or consulting services.

  • Self-paced online courses with expert support
  • Live virtual training sessions
  • Custom corporate training packages
  • Audit-proven checklists and templates

Based in Miami, Florida, MDR Consultants has helped thousands of medical device professionals advance their regulatory expertise globally.

Internal and Vendor Audits and Tools

Internal and Vendor Audits and Tools for Medical Devices

Looking for Internal and Vendor Audits and Tools that actually simplify your QMS?

At MDR Consultants, we deliver actionable solutions—led by former Notified Body auditors—tailored to your team and product lifecycle.

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Why Internal and Vendor Audits Matter

A robust internal audit program is the backbone of ISO 13485 compliance. Our Internal and Vendor Audits and Tools are built to support manufacturers through every phase of their QMS journey. With MDR Consultants, you gain a partner who understands FDA, EU MDR, and MDSAP requirements inside and out.

Whether you’re preparing for an FDA inspection, MDSAP audit, or supplier qualification, our experts provide clear pathways, tools, and documentation strategies. We help reduce audit stress, close gaps, and build QMS programs that drive continual improvement.

  • Internal and vendor audit execution
  • Audit checklist and gap assessment tools
  • Remediation planning and coaching
  • Training for quality, RA, and cross-functional teams

Our consultants don’t just audit—they empower your team with scalable, compliant systems that keep you inspection-ready. From one-time engagements to ongoing audit partnerships, we support your success.

Exclusive Audit Tools Coming Soon

We’re developing powerful, practical audit tools to streamline your compliance process. Be the first to access:

  • ISO 13485 Internal Audit Checklist
  • EU MDR QMS Compliance Checklist
  • FDA QMSR Gap Assessment Tool

Sign up for updates and get early access when we launch!

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Ready to Improve Your QMS Audit Program?

Let’s strengthen your quality management system with our services. Book your free consultation today.

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