We provide independent, audit-only services for organizations operating in highly regulated environments. Our audit experience spans multiple regulated industries, with a focus on quality management systems, process controls, supplier oversight, and regulatory compliance.
Medical Devices
We support medical device manufacturers of all sizes — from small and medium enterprises to contract manufacturers and critical suppliers — with independent internal and supplier audits.
Our audit experience in this sector includes:
- Quality management systems under ISO 13485 and FDA QMSR
- Validated manufacturing processes and special processes (IQ, OQ, PQ)
- Medical device production, including implantable and single-use devices
- Precision metal and polymer manufacturing for medical applications
- Electromechanical device manufacturing environments
- Supplier qualification, monitoring, and risk management
Audits are conducted with a focus on process controls, validation practices, design controls, and operational risk — reflecting the expectations of regulators and major OEM customers.
Diagnostics & IVD
We bring hands-on experience in diagnostic and laboratory-based environments, providing a strong foundation for auditing organizations in this sector.
Our experience supports effective auditing of:
- Diagnostic device and IVD manufacturers
- Laboratory-related processes and analytical methods
- Data integrity and controlled laboratory processes
- Suppliers supporting diagnostic and IVD products
- Quality systems under ISO 13485 and applicable regulatory frameworks
This background includes contribution to peer-reviewed research publications and early-stage intellectual property development, providing deeper insight into the scientific and technical foundations of diagnostic products.
Aerospace
We support aerospace organizations and their suppliers with independent audits aligned to the rigorous standards expected in this industry.
Our aerospace audit services address:
- Quality management systems under ISO 9001 and applicable aerospace frameworks
- Supplier qualification and ongoing supplier monitoring
- Process controls and special process validation
- Risk management and regulatory compliance
- Customer-specific and contractual audit requirements
Audits are scaled appropriately to organizational size and complexity while maintaining the rigor, objectivity, and consistency expected by aerospace customers and regulators.
Other Regulated Industries
While our primary focus is on medical devices, diagnostics, and aerospace, our audit methodology and quality system expertise may be applicable to other highly regulated industries. If your organization operates under regulatory oversight and requires independent, OEM-grade audits, we welcome the opportunity to discuss your needs.
Not Sure If We Can Help?
Contact us for a free initial consultation to determine whether our services are aligned with your industry and audit requirements.