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MEDICAL DEVICE SINGLE AUDIT PROGRAM AUDIT MODEL 20170106 MD SAP AU P0002.004 2 Tables of Contents Overview ...............................................................................................................

How to fill out mdsap audit model

How to fill out mdsap audit model:

1. Familiarize yourself with the mdsap audit model guidelines provided by the relevant regulatory body.
2. Review the specific requirements and expectations outlined in the mdsap audit model.
3. Gather all necessary documentation and information required for the audit, such as quality management system records, risk management documentation, and relevant product information.
4. Conduct a thorough assessment of your organization's existing processes and procedures to identify any gaps or areas for improvement in relation to the mdsap audit model requirements.
5. Develop a comprehensive plan to address any identified gaps and ensure compliance with the mdsap audit model.
6. Complete the necessary forms, templates, and checklists provided by the regulatory body, ensuring that all required information is accurately documented.
7. Conduct internal audits and reviews to verify that your organization's practices align with the mdsap audit model requirements.
8. Make any necessary adjustments or corrective actions based on the findings of the internal audits.
9. Submit the completed mdsap audit model documentation to the regulatory body within the specified timeframe.
10. Prepare for and participate in any follow-up assessments or inspections that may be required.

Who needs mdsap audit model:

1. Medical device manufacturers seeking to market their products in multiple international markets, including Brazil, Canada, Japan, and the United States.
2. Companies that want to streamline and harmonize their regulatory compliance efforts by adhering to a single audit model recognized by multiple regulatory authorities.
3. Organizations looking to enhance their quality management systems and ensure that they meet international standards and regulations for medical devices.
4. Regulatory bodies and authorities responsible for overseeing medical device approval and market access, who may require organizations to undergo mdsap audit model assessments.

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What is mdsap audit model?

The MDSAP audit model is a program that allows medical device manufacturers to undergo a single regulatory audit of their quality management system that satisfies the requirements of multiple regulatory authorities.

Who is required to file mdsap audit model?

Medical device manufacturers who want to sell their products in countries that are part of the MDSAP program are required to undergo the MDSAP audit.

How to fill out mdsap audit model?

To fill out the MDSAP audit model, manufacturers need to provide detailed information about their quality management system, processes, and documentation.

What is the purpose of mdsap audit model?

The purpose of the MDSAP audit model is to harmonize regulatory requirements for medical devices across participating countries and simplify the auditing process for manufacturers.

What information must be reported on mdsap audit model?

Manufacturers must report information about their quality management system, documentation, processes, and compliance with regulatory requirements.