Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) is an international initiative that streamlines regulatory audits for medical device manufacturers. It allows participating countries, including the United States, Canada, Brazil, Australia, and Japan, to conduct a single audit that assesses compliance with the relevant regulations of multiple countries.
Under MDSAP, a qualified auditing organization performs a comprehensive audit of a manufacturer's quality management system (QMS) according to the applicable standards and regulations of each participating country. The audit covers areas like quality policies, documentation, risk management, design and development, production, and post-market activities.
The advantage of MDSAP lies in its efficiency and consistency. Manufacturers undergo a single audit that meets the requirements of multiple regulatory authorities, reducing redundancy and saving time and resources. This unified approach enhances global market access and harmonizes quality standards across different regions.
Successfully completing an MDSAP audit demonstrates a commitment to quality and regulatory compliance on an international scale. It simplifies the audit process and facilitates access to diverse markets while fostering trust among regulators, healthcare professionals, and patients.
In summary, the Medical Device Single Audit Program (MDSAP) offers a streamlined approach to regulatory audits for medical device manufacturers. By undergoing a single audit that satisfies multiple countries' requirements, manufacturers can enhance their global market access and demonstrate their dedication to quality and compliance.
We provide technical support to assist in the establishment of Quality Management System for compliance with MDSAP.
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