Medical Device & Diagnostic Audit Services

Maintain Robust Quality Systems, Meet Evolving Regulatory Requirements, and Remain Inspection-Ready

Ensure compliance, mitigate risk, and stay audit-ready with ProPharma's expert-led audit solutions for medical devices and diagnostic products. In today’s complex and fast-evolving regulatory environment, maintaining a strong, inspection-ready quality system is critical to product success and market access.

Whether you're preparing for an FDA inspection, pursuing ISO 13485 or MDSAP certification, responding to EU MDR/IVDR requirements, or managing a global supplier network, ProPharma's expert team of medical device auditors provide in-depth evaluations, practical recommendations, and scalable support tailored to your specific needs. Our audits are designed to not only identify gaps, but to strengthen your quality system, support continuous improvement, and position your organization for long-term success.

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Stay Audit-Ready. Stay Compliant.

With a knowledge base of regulations and international standards across all global markets our experienced auditors provide the insights you need to close gaps, enhance compliance, and minimize regulatory risk. Ready to elevate your audit program? Contact us today to get started. 

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Comprehensive Audit Services Across the Device Lifecycle

ProPharma supports a full range of audit types tailored to medical device and diagnostic manufacturers, from early-stage readiness assessments to complex post-inspection remediation efforts.

Types of Medical Device & Diagnostic Audits We Support:

FDA QSR/QMSR Compliance Audits

Ensure alignment with 21 CFR Part 820 and the FDA’s evolving Quality Management System Regulation (QMSR), harmonized with ISO 13485:2016.

ISO 13485:2016 Certification Readiness & Internal Audits

Evaluate and strengthen your Quality Management System (QMS) ahead of certification audits or internal evaluations.

MDSAP Certification Readiness & Internal Audits

Assess readiness for the Medical Device Single Audit Program (MDSAP), covering multiple regulatory authorities under one audit framework.

EU MDR & IVDR Compliance Audits

Identify gaps in technical documentation, quality processes, and postmarket surveillance systems to meet EU MDR 2017/745 and IVDR 2017/746 requirements.

Supplier Qualification & Compliance Audits

Evaluate critical suppliers for compliance with FDA QSR/QMSR and ISO 13485:2016 to support risk-based supplier management strategies.

Mock FDA Inspections & Inspection Readiness Audits

Simulate FDA inspections to uncover potential gaps, coach internal teams, and strengthen inspection readiness protocols.

Design History File (DHF), Device Master Record/Medical Device File, and Technical File Audits

Review key product and process documentation for completeness, traceability, and compliance with applicable regulatory requirements.

Software as a Medical Device (SaMD) & Digital Health Audits

Specialized audits for software-based and AI/ML-enabled products, including validation documentation and cybersecurity assessments.

Post-Inspection Compliance Audits

Independent assessments following FDA 483s, Warning Letters, or other enforcement actions to verify remediation effectiveness.

Proven Experience. Trusted Results.

Your Global Partner for Medical Device and Diagnostic Auditing

ProPharma is the global leader in quality and compliance consulting for medical devices, diagnostics, and combination products. With a proven track record and unmatched technical expertise, we support clients across the full product lifecycle—helping you stay compliant, audit-ready, and focused on innovation.

Why Life Sciences Companies Trust ProPharma 

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1,500+ audits completed across the life sciences industry in the last 3 years

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Audit support in 30+ countries, including the US, EU, LATAM, and APAC regions. 

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Auditor expertise spanning 10–25+ years in device, diagnostic, and combination product audits.
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Successful remediation support for FDA 483s, Warning Letters, and complex compliance challenges.
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Specialized knowledge of combination product and SaMD/digital health regulatory frameworks.
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CAPA planning, implementation, and post-audit coaching to drive sustainable improvement.
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Flexible delivery models: onsite, remote, or hybrid auditing tailored to your operations.
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Access to broader GxP audit services including GMP, GLP, and GCP for end-to-end quality system support.

What Sets ProPharma Apart?

Global Reach with Local Expertise

Audits conducted in 30+ countries with in-depth knowledge of FDA, EU MDR/IVDR, ANVISA, MHRA, MDSAP, and more. 

Global Reach with Local Expertise

Audits conducted in 30+ countries with in-depth knowledge of FDA, EU MDR/IVDR, ANVISA, MHRA, MDSAP, and more. 

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Experienced, Cross-Functional Audit Teams

Led by former FDA investigators, Notified Body assessors, and QA/RA experts with technical depth in manufacturing, microbiology, engineering, software...

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Experienced, Cross-Functional Audit Teams

Led by former FDA investigators, Notified Body assessors, and QA/RA experts with technical depth in manufacturing, microbiology, engineering, software validation, and digital health.

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Scalable, End-to-End Audit Management

From project coordination to logistics and recurring program oversight, we offer full-service outsourcing tailored to your audit needs.

Scalable, End-to-End Audit Management

From project coordination to logistics and recurring program oversight, we offer full-service outsourcing tailored to your audit needs.

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Actionable, Risk-Based Approach

We go beyond simply identifying gaps by delivering strategic remediation, team training, and sustained compliance support.

Actionable, Risk-Based Approach

We go beyond simply identifying gaps by delivering strategic remediation, team training, and sustained compliance support.

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Consistent, Efficient Delivery Model

Dedicated project managers and audit leads ensure seamless execution across global sites and complex audit programs. 

Consistent, Efficient Delivery Model

Dedicated project managers and audit leads ensure seamless execution across global sites and complex audit programs. 

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Insightful, Regulatory-Alignment Reporting

Our narrative audit reports provide system-level analysis, traceability to applicable regulations, and clear, prioritized recommendations.

Insightful, Regulatory-Alignment Reporting

Our narrative audit reports provide system-level analysis, traceability to applicable regulations, and clear, prioritized recommendations.

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Partner with ProPharma for Trusted Audit Support

Whether you need a single supplier audit, a comprehensive mock FDA inspection, or an outsourced global audit program, ProPharma delivers expert-driven, risk-based solutions tailored to your business.

Contact us today to discuss your audit needs and learn how ProPharma can help you maintain compliance, strengthen your QMS, and stay inspection-ready.

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