Expert Services

Internal Audit Services

Internal Audit Services

At AQC, we offer comprehensive internal audit services to help medical device and in vitro diagnostic (IVD) manufacturers ensure compliance with ISO 13485, MDR 2017/745, IVDR 2017/746, MDSAP, and FDA QSR (21 CFR Part 820). Our expert auditors provide independent, objective assessments to identify gaps, improve processes, and prepare for external audits.

Why Internal Audits Are Essential?

  • Ensure Compliance – Meet regulatory requirements (ISO 13485, MDR, IVDR, FDA, MDSAP)
  • Identify & Address Risks – Detect non-conformities before external audits
  • Improve Quality Processes – Strengthen your Quality Management System (QMS)
  • Prepare for Notified Body & Regulatory Audits – Reduce the risk of audit failures
  • Enhance Supplier & Manufacturing Compliance – Ensure supply chain reliability

Our Internal Audit Services

ISO 13485:2016 & EN ISO 13485:2021 Internal Audits

  • Assess QMS effectiveness & regulatory compliance
  • Identify gaps & recommend corrective actions
  • Prepare audit reports & follow-up plans

EU MDR 2017/745 & IVDR 2017/746 Compliance Audits

  • Verify compliance with Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR)
  • Review Technical Documentation & Post-Market Surveillance (PMS)
  • Conduct Mock Notified Body Audits

FDA 21 CFR Part 820 (QSR) Internal Audits

  • Assess compliance with US FDA Quality System Regulations (QSR)
  • Identify non-conformities before an FDA inspection
  • Implement CAPA & risk management strategies

MDSAP (Medical Device Single Audit Program) Readiness Audits

  • Ensure compliance with MDSAP requirements
  • Audit across jurisdictions (USA, Canada, EU, Australia, Brazil, Japan)
  • Identify gaps & recommend corrective actions

Supplier & Manufacturing Audits

  • Evaluate supplier compliance with ISO 13485 & MDR/IVDR
  • Conduct on-site & remote supplier audits
  • Identify risks in the supply chain & manufacturing processes

GAP Analysis & Audit Readiness Assessments

  • Pre-assessments before Notified Body, Competent Authority, or FDA inspections
  • Identify & resolve non-conformities
  • Support corrective & preventive actions (CAPA)
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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