Internal and supplier auditing for medical devices

Internal & supplier auditing

Regular internal and supplier audits are critical for maintaining compliance, improving quality, and mitigating risks. Poorly executed audits can result in undetected non-conformities, regulatory penalties, and supply chain vulnerabilities.

Our expert consultants can support you in performing audits when resource or competency is limited, and ensure that your auditing processes are thorough, effective, and aligned with ISO 13485, MDSAP, and FDA requirements.

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Ensuring compliance and quality through expert auditing

Many companies struggle with resource constraints, complex regulatory requirements, and evolving supplier landscapes. Our experienced auditors provide independent, objective assessments to help you:

  • Remain compliant and up-to-date with your audit schedule when resource and/or competency are limited
  • Identify gaps in your QMS and address non-conformities before regulatory inspections.
  • Ensure suppliers meet quality and compliance requirements, reducing supply chain risks.
  • Maintain continuous improvement by providing actionable insights from audit findings.
  • Prepare for external audits and certification bodies, minimising the risk of non-compliance.

Why use our support with internal and supplier auditing?

Effective auditing requires specialised expertise to interpret regulations, assess processes, and implement corrective actions. Training internal auditors is time consuming. Our consultants provide comprehensive support for:

  • Internal audits (ISO 13485, MDSAP, FDA) – Planning, conducting, and reporting internal audits to ensure compliance, identify weaknesses and improve your QMS.
  • Supplier audits – Evaluating manufacturers, component suppliers, and service providers for compliance with ISO 13485, MDSAP, and FDA expectations.
  • Corrective & preventive actions (CAPA) management – Implementing effective follow-up actions to resolve findings and prevent recurrence.
  • Regulatory & compliance training – Educating teams on best practices for auditing and supplier oversight.
Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.