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.

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.