Our audit services are grounded in hands-on experience within regulated manufacturing and laboratory-based environments — ensuring assessments reflect both documented requirements and real operational execution.
Manufacturing & Process
Experience leading audits in manufacturing environments involving:
- Validated manufacturing processes and special processes (IQ, OQ, PQ)
- Precision metal and polymer manufacturing
- Medical device production, including implantable and single-use devices
- Electromechanical device manufacturing
Diagnostics & Research
Hands-on involvement in diagnostic and laboratory-based environments, providing strong understanding of:
- Analytical methods and data integrity
- Controlled laboratory processes
- Diagnostic and IVD product suppliers
- Peer-reviewed research and IP development
Audit & Quality Systems
Leading internal and supplier audits across highly regulated industries:
- Quality management systems and process controls
- Supplier oversight and regulatory compliance
- ISO 13485, ISO 9001, FDA QMSR
- Company- and customer-specific requirements
International Experience
On-site and remote audit experience across multiple regions:
- On-site supplier audits in Mexico
- Remote audits with European suppliers
- Multiple regulatory environments
- Cross-cultural audit execution
Regulated Industry Exposure
Experience spans organizations of varying size and maturity, including small and medium manufacturers, contract manufacturers, and critical suppliers operating under regulatory and customer oversight. Audits are scaled appropriately to organizational context while maintaining rigor, objectivity, and consistency.
Language Capability
Audit services available in English and Spanish. Audits may be conducted in either language or a combination of both. Reports issued in either language as agreed during scoping.
Professional Conduct
All audit activities are conducted in accordance with professional auditing principles, with emphasis on independence, confidentiality, and evidence-based evaluation.