MDSAP Audit Checklist

Identify gaps in your company's quality management system (QMS) and take corrective action through Lumiform's free MDSAP audit checklist.

Go paperless, conduct inspections easily and solve issues quicker with your teammates.

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Use Lumiform's FREE MDSAP audit checklists to determine if the manufacturer's Quality Management Systems meet ISO 13485 requirements.

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ISO 13485:2016 Standard Checklist

Use this checklist to find gaps in the company’s current methods.

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ISO 13485 Audit Checklist

Use this checklist to find out if the company’s QMS is aligned with the ISO 13485:2016 standard.

Download template

What does MDSAP entail?

The Medical Device Single Audit Program (MDSAP) is a certification program for the quality management system (QMS) of manufacturers who sell medical devices. MDSAP audit checklists help ensure compliance with ISO 13485:2016 and the verification of this by regulatory authorities. The MDSAP Audit Checklist is used to assess the readiness of medical device manufacturers for a MDSAP certification.

This article briefly covers:

1. Tips for MDSAP certification.

2. The benefits of the Lumiform app for MDSAP

Tips for MDSAP certification

  • Find out about ISO 13485:2016 and RA requirements in Germany.

  • Identify areas for improvement of the QMS system, e.g. with the GAP analysis.
  • Perform quality monitoring audits and record relevant results.

  • Define the company's competencies and define the training requirements for obtaining MDSAP certification and monitor compliance on a regular basis.

  • Partner with an auditing organization for MDSAP certification.

  • Partner with an auditing organization for MDSAP certification.

Advantages of the Lumiform app for an MDSAP audit.

With the Lumiform mobile app, you can easily perform any type of quality and security inspection using a tablet or smartphone - online or offline. With the desktop software you can create checklists and evaluate the data collected in the field. This significantly reduces the risk of quality loss, accidents at work, documentation errors and damage to your reputation.

Digitize checklists and internal processes with Lumiform:

  • The flexible checklist builder from Lumiform helps you to convert any individual paper list into a digital checklist without much effort.

  • In addition, we offer more than 9,000 ready-made templates to help companies get started digitally in no time.

  • Using the super intuitive mobile App, you and your teammates conduct check in the field with ease and in no time.

  • All results, images and comments are automatically bundled in a digital report..

  • Comprehensive analyses help you to identify inefficient areas in your company more quickly and thus to continuously improve your auditing and inspection processes.