MDSAP Preparation

Qualisure offers comprehensive support for the Medical Device Single Audit Program (MDSAP), enabling manufacturers to meet the regulatory requirements of multiple major markets through a single, harmonized audit process.

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What is MDSAP?

The Medical Device Single Audit Program allows a recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the requirements of multiple regulatory authorities, including those of Australia, Brazil, Canada, Japan, and the United States.

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Our MDSAP Services Include:

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• Gap Assessment: Detailed review of your current quality management system and documentation against MDSAP requirements, identifying gaps related to ISO 13485 and specific country regulations.

• Audit Preparation: Step-by-step guidance through the MDSAP audit model, including process mapping, documentation alignment, and readiness checks for all participating jurisdictions.

• Mock Audits: Simulation of the MDSAP audit process to identify potential nonconformities and ensure your team is confident and prepared for the real audit.

• Corrective Action Planning: Support in developing and implementing effective corrective actions for any identified gaps or weaknesses, ensuring long-term compliance.

• Multi-Jurisdictional Expertise: Advice tailored to your specific target markets, whether you are seeking compliance for one, two, or multiple jurisdictions.

• Ongoing Support: Post-audit support to address findings, respond to regulatory feedback, and maintain continuous readiness for surveillance or re-certification audits.

 

Benefits of MDSAP Preparation with Qualisure:

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• Streamlined access to multiple global markets with a single audit process.

• Reduced audit fatigue and duplication of effort across regulatory jurisdictions.

• Confidence in meeting the latest requirements from all participating authorities.

• Practical, actionable recommendations from experienced regulatory consultants.

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Let Qualisure guide you through the complexities of MDSAP, helping you achieve efficient, effective, and sustainable compliance for global market success.