MDSAP

Streamlining Global Compliance with a Single Audit

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to satisfy the quality management system requirements of multiple regulatory authorities.- IQzyme offers expert guidance and support to help you navigate the MDSAP process, ensuring compliance across multiple jurisdictions with a single, efficient audit.

Our MDSAP Services

MDSAP Readiness Assessment

Gap Analysis: Conduct a comprehensive gap analysis to identify areas of your quality management system (QMS) that require improvement to meet MDSAP requirements.

Readiness Evaluation: Assess your organisation’s readiness for MDSAP and provide recommendations for closing any compliance gaps.

Quality Management System Optimization

QMS Enhancement: Assist in optimising your QMS to align with the MDSAP requirements, including ISO 13485 and specific regulatory requirements of participating countries.

Documentation and Process Improvement: Enhance documentation and processes to ensure they meet the standards set by MDSAP and relevant regulatory bodies.

Audit Preparation and Support

Pre-Audit Training: Provide training and workshops to prepare your team for the MDSAP audit, focusing on key areas of compliance and auditor expectations.

Mock Audits: Conduct mock audits to simulate the MDSAP audit process, helping identify potential issues and areas for improvement before the official audit.

MDSAP Audit Coordination

Audit Scheduling: Assist with the coordination and scheduling of the MDSAP audit with an authorised Auditing Organisation (AO).

Audit Facilitation: Provide support during the audit process, facilitating communication and addressing any queries from the auditors.

Post-Audit Support and Continuous Improvement

Corrective Actions: Help develop and implement corrective action plans to address any non-conformities identified during the audit.

Continuous Improvement: Support ongoing improvements to your QMS to maintain compliance and enhance operational efficiency.

Why Choose IQzyme for MDSAP?

Regulatory Expertise: Our team has extensive experience in preparing medical device companies for MDSAP, ensuring compliance with the diverse requirements of multiple jurisdictions.

Tailored Solutions: We offer customized solutions to align your QMS with MDSAP standards, meeting the unique needs of your organization and products.

Comprehensive Support: From initial assessment to post-audit improvements, we provide end-to-end support to streamline your MDSAP process.

Commitment to Quality: We are dedicated to helping you achieve and maintain high-quality standards, ensuring your devices meet global regulatory requirements.

Simplify Your Global Compliance with IQzyme

Achieve global regulatory compliance with a single, streamlined audit process through the Medical Device Single Audit Program. Contact IQzyme today to learn how we can support your MDSAP journey and enhance your international market access.