ISO 13485 Internal Audits for Medical Device Compliance

Independent. Risk-Based. Inspection-Ready.

ISO 13485 Internal Audits That Strengthen Compliance and Readiness

Wintersmith Advisory conducts ISO 13485 internal audits that help medical device companies evaluate QMS compliance, identify nonconformities, and prepare for certification, surveillance, or regulatory inspections.

Why work with Wintersmith Advisory for ISO 13485 audits?

• ISO 13485:2016-aligned internal audits

• Independent, impartial execution per ISO 19011

• Verification of risk management, design controls, and traceability

• Nonconformance identification and CAPA guidance

• Supplier audit planning and file review support

• Audit readiness for FDA, MDSAP, and notified body reviews

Internal Audits That Support Regulatory Success

Internal audits are a core requirement of ISO 13485—and essential for medical device organizations operating in regulated environments. Wintersmith Advisory delivers structured, independent internal audits designed to uncover system weaknesses, ensure regulatory alignment, and drive continuous improvement.

Tailored Audit Execution for Real-World Device Compliance

Our audits are tailored to your scope and risk profile, with a focus on product lifecycle controls, design documentation, supplier quality, and post-market surveillance processes. We evaluate procedures and records, interview key personnel, and provide clear, actionable reports that help your team respond with confidence. Whether preparing for a certification body, MDSAP audit, or FDA inspection, we help ensure you’re ready.

Built on Standards. Informed by Industry. Focused on Improvement.

• ISO 13485:2016 and ISO 19011-aligned auditing practices

• Focused on risk, safety, and regulatory performance

• Experience supporting FDA, MDSAP, and EU MDR audits

• Audit reports designed to drive corrective action and improvement

Let’s Ensure Your QMS Is Ready for Scrutiny

Need an ISO 13485 internal audit you can trust?
Let’s talk about your QMS and how we can support your compliance goals.