Global Medical Device Audit Company
Your Trusted Global QMS Audit Partner
We are a dedicated audit company ensuring the highest standards of compliance, safety and quality across the medical device industry worldwide.
Our team of expert quality and regulatory auditors deliver comprehensive risk-based audits, tailored to the evolving needs of medical device manufacturers, suppliers and distributors.
We provide comprehensive medical device audit services including Internal Audits, Supplier Audits, Supplier Qualification assessments, Mock FDA Inspections and QMS Gap Assessments to ensure regulatory compliance, supplier integrity and continual improvement across your medical device quality system.
Audit Services
Internal
Audits
Supplier
Audits
Mock FDA
Inspections
Supplier
Qualification
QMS Gap Assessments
Key Benefits
Outsourcing brings specialised knowledge, objectivity, and efficiency, all of which contribute to stronger, more reliable compliance for your organisation. Our key benefits include rigorous regulatory compliance expertise, proactive risk management to ensure device safety, market access and continuous quality improvement.
Access to Experts
Objectivity and Independence
Resource Efficiency
Cost Predictability
Standards We Audit To
We audit to internationally recognised medical device quality and regulatory standards, including ISO 13485, MDSAP, MDR and FDA requirements.
Request an Audit
Click the button to contact our medical device audit specialists to discuss your compliance and audit requirements.