Auditing & Assessment

Auditing & Assessment Services

Thorough. Independent. Inspection‑Ready.

As regulatory scrutiny continues to intensify across the EU MDR and IVDR regulatory landscape, manufacturers must ensure their quality systems, technical documentation, and clinical evidence are consistently compliant, not only at audit time. AKRA TEAM provides independent medical device and IVD auditing and assessment services designed to identify gaps early, confirm regulatory alignment, and prepare your organization confidently for Notified Body, Competent Authority, and FDA inspections.

Our audits go beyond checklist compliance. We apply deep regulatory expertise and real‑world inspection insight to deliver clear, actionable findings that support regulatory approval, audit defense, and continuous quality improvement.
We help you know where you stand before regulators do.

Internal QMS Audits

We conduct rigorous internal QMS audits aligned with applicable international standards and regulations, including ISO 13485, EU MDR, EU IVDR, ISO 14155, MDSAP, and relevant MDCG guidance. Our audits assess both documentation and system effectiveness, ensuring that your Quality Management System is not only compliant on paper, but fully implemented and audit‑ready in practice.

Supplier & External Audits

AKRA TEAM performs independent supplier and external audits to assess critical suppliers, outsourced processes, and economic operators across your supply chain. These audits help demonstrate effective supplier control, address third‑party compliance risks, and meet growing regulatory expectations under MDR and IVDR supplier oversight requirements.

MDR / IVDR Readiness Assessments

Our MDR and IVDR readiness checks provide structured, evidence‑based gap analyses against current and evolving regulatory requirements. By identifying non‑conformities early, we help you address deficiencies proactively — reducing remediation burden, avoiding conformity assessment delays, and improving notified body outcomes.

Technical Documentation & Clinical Evaluation Assessments

We offer expert pre‑submission assessments of your Technical Documentation, Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), and supporting clinical evidence. These reviews benchmark your files against Notified Body expectations, audit trends, and regulatory best practices, ensuring issues are addressed before formal submission or surveillance review.

Our goal is to strengthen your TD and clinical evidence before notified body review.