MDSAP Internal Audit


Internal audits serve as a proactive mechanism to identify, rectify, and prevent potential pitfalls in your quality management processes. Beyond mere compliance, internal audits illuminate areas for improvement, fostering a culture of continuous enhancement that elevates your organization’s operations.

Why Choose Specculo for MDSAP Audits?

Expertise in Medical Device Regulations: Our team comprises seasoned professionals with in-depth knowledge of MDSAP and country-specific requirements.

Tailored Audit Approach: We recognize that each organization is unique. Our audit process is customized to fit the specific needs and intricacies of your operations.

Comprehensive Assessment: Our audits cover all aspects of ISO 13485:2016 and MDSAP ensuring a thorough examination of your quality management system.

Risk-Based Methodology: We employ a risk-based approach, identifying potential areas of non-compliance and offering strategic recommendations for improvement.

Value-Added Insights: Beyond compliance, our audits provide actionable insights to enhance operational efficiency, reduce risks, and optimize your QMS.

Our MDSAP Audit Process

Pre-Audit Consultation:

  • Initial discussion to understand your organization’s structure, processes, and current quality management system.
  • Preliminary assessment to identify potential areas of concern.


  • Conducting a detailed on-site or remote audit, engaging with key stakeholders and personnel.
  • Verification of compliance with ISO 13485:2016 and MDSAP and applicable regulatory requirements.

Audit Report and Findings:

  • Comprehensive report detailing audit findings, observations, and areas for improvement.
  • Clear documentation of non-conformities, if any, with guidance on corrective actions.

Corrective Action Assistance:

  • Collaborative support in developing and implementing corrective actions to address identified non-conformities.

Follow-Up Audit (Optional):

  • Subsequent audit to verify the effectiveness of corrective actions and ensure sustained compliance.

Contact Us for Your MDSAP Audit Needs

Elevate your quality management system to meet and exceed ISO 13485:2016 requirements with our specialized Internal Audit Services.

Contact us today to discuss your requirements and schedule an initial consultation.

Simplify your compliance workflow.