Experienced auditor conducting expert medical device audit.

Our Medical Device Audit Services

We provide experienced, certified auditors with in-depth knowledge of global regulatory frameworks and industry best practices. This ensures your audits are thorough and compliant with the latest standards and regulations.

Who We Work With

Medical Device Manufacturers

Distributors & Importers

Component & Material Suppliers

Established Enterprises

Shipping containers containing medical devices for supply and distribution around the globe.

Audit being conducted in a modern medical device production facility.

Established quality and regulatory directors discussing continuous improvement initiatives.

Medical device engineer working on technical blueprints and mechanical parts required for medical devices.

Start-Ups

Three entrepreneurs designing and developing a novel medical device.

GMD Audits expert auditor and production engineer in a high-tech medical device manufacturing facility.

Internal Audits

Comprehensive review of your internal quality management system (QMS) to ensure ongoing compliance and identify opportunities for improvement.

KEY BENEFIT: Early detection of gaps and proactive risk management for sustained compliance.

Auditor and two warehouse operators inspecting a package using a inside a large medical device storage facility.

Supplier Audits

Evaluation of your suppliers’ quality management systems (QMS) to ensure they meet regulatory and contractual requirements (Supplier Quality Agreements).

KEY BENEFIT: Strengthen supply chain reliability and regulatory compliance.

Supplier Qualification

In-depth assessments to qualify new suppliers or re-qualify existing ones, focusing on their ability to consistently deliver compliant products or services.

KEY BENEFIT: Ensures only capable and compliant suppliers are engaged, reducing operational risk.

Magnifying glass focusing on the U.S. Food and Drug Administration (FDA) representing a mock FDA Inspection.

Mock FDA Inspections

Simulated FDA inspections to prepare your team and processes for real regulatory audits reducing the risk of non-conformities.

KEY BENEFIT: Boosts audit readiness and confidence, minimising surprises during actual inspections.

A magnifying glass placed over a stack of QMS documents signifying Quality Management System gap assessment.

QMS Gap Assessments

A QMS Gap Assessment is a comprehensive review of your quality management system (QMS) to identify areas where current practices do not meet regulatory or standard requirements, enabling targeted improvements for compliance and effectiveness.

KEY BENEFIT: Early detection of compliance gaps and proactive risk management, which supports sustained regulatory compliance and continuous improvement.

Request an Audit

Click the button to contact our medical device audit specialists to discuss your compliance and audit requirements.