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Get MDSAP certified with an MDSAP audit checklist

Find out what your company needs to do to get MDSAP certified and discover tips on how to pass an audit. Identify gaps in your company's quality management system (QMS) and take corrective action with an audit checklist.

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. What does MDSAP entail?

2. MDSAP essential requirements

3. Tips for MDSAP certification.

4. The benefits of an app for MDSAP

What does MDSAP entail?

Before globalization, countries could get away with setting their own industry standards and regulations, but now, the economy spans continents not just countries. Once unfeasible distances are being closed in a matter of hours. International trade is flourishing, and globalization has called for standardization, especially in industries where product defects could potentially cost someone their life.

An MDSAP certification ensures the regulation of all medical devices within participating countries. Companies who are doing business in or with the United States, Japan, Canada, Australia, or Brazil must be MDSAP certified. To reiterate, that means medical device companies that reside outside of these countries, and who do not hold the certification, cannot do business with these countries.

What Are the Essential Requirements for a MDSAP Certification?

Although medical device certification can be a tedious process, the good news is it only involves scheduled audits, meaning that there are no surprise visits. Companies can prepare for the auditor and are even provided a list of criteria that must be met in order to pass. They can also choose which third-party auditing organization will perform the inspection. Among other benefits, getting MDSAP certified is essentially a one-for-five deal. One audit will certify your company to do business in five different regulatory countries.

But first, in order to reap the benefits, a company must first pass its audit. To do that, companies must adhere to the regulations set forth by ISO: 13485:2016 as described below:

Medical Device Tracking Requirements

Companies have to have a system in place to track medical devices back to the manufacturer of a Class II or Class III medical device if it meets any of the following criteria:

  • If device defects could have adverse medical consequences to the patient’s health
  • If the medical device is intended to be implanted within the human body for over a one year period
  • If the medical device has life-supporting capabilities that are in use outside of a medical facility

Quality Management System Regulations

Companies have to adhere to strict quality management and control system regulations and maintain their integrity to stated international requirements in order to ensure medical devices are safe for extended use.

The following information must be included in a medical device company’s quality management system:

  • Quality Policy
  • Organization
  • Responsibility
  • Resources
  • Management representative
  • Management Review
  • Quality Planning
  • Quality Systems procedures

Medical Device Reporting Regulations

This section of the regulatory requirements refers to the reporting of device failures and defects that lead to injury or death. A device user facility must:

  • Report deaths or injuries caused or thought to have been caused by their medical device no longer than ten business days after the event occurred
  • Provide documentation on any deaths or injuries caused by the medical device
  • Submit an annual report on the findings of the medical device
  • Submit any supplemental reports on findings that were discovered after submitting the annual report

Medcial Device Document Regulations

Medical device companies must provide documentation on every role within the quality management system (roles include personnel within and outside the company, for example, the distributor, manufacturer, importer, etc.) and keep documents up to international regulatory requirements. These documents include the following:

  • Documentation that includes a list of procedures that’s in compliance with international standards
  • A manual on quality control that includes product information on every medical device within their jurisdiction
  • Medical device file that is kept organized so no documents are lost

Here you can see the complete list of the MDSAP FDA procedures.

Tips for MDSAP Certification

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

ECG device in a hospital facility

Advantages of an 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 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 can conduct checks in the field with ease.
  • 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.

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a person conducting an MSDAP audit checklist
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