Streamlining Global Compliance Through a Single Audit
The Medical Device Single Audit Program (MDSAP) enables manufacturers to meet the quality management system requirements of multiple regulatory authorities through a single audit. Medral Global offers expert support to help you navigate the MDSAP process efficiently, ensuring compliance across various global markets with minimal disruption.
Our MDSAP Services
Readiness Evaluation and Gap Analysis
- Gap Identification: We perform a detailed gap analysis to pinpoint areas where your current quality management system (QMS) falls short of MDSAP standards.
- Compliance Readiness: Evaluate your organization’s preparedness for MDSAP and offer clear steps to close identified gaps.
Quality System Alignment and Enhancement
- QMS Optimization: We assist in upgrading your QMS to align with MDSAP requirements, including ISO 13485 and country-specific regulations.
- Process and Documentation Improvement: Enhance procedures and records to ensure full alignment with MDSAP expectations and regulatory demands.
Pre-Audit Preparation and Training
- Internal Training: Equip your team with knowledge through targeted training sessions focused on audit expectations and key areas of compliance.
- Mock Audits: Simulate real audit scenarios to identify potential non-conformities and strengthen your audit readiness.
Audit Coordination and On-Site Support
- Scheduling Assistance: Coordinate audit logistics with authorized Auditing Organizations (AOs) to ensure a smooth and timely process.
- Audit Facilitation: Support your team throughout the audit, helping manage communications and resolve auditor inquiries in real-time.
Post-Audit Support and QMS Advancement
- Corrective Action Plans: Develop and implement effective corrective actions to resolve any audit findings.
- Ongoing Improvement: Provide guidance for continuous improvement initiatives that enhance compliance and operational performance.
Why Partner with Medral Global for MDSAP?
- Multinational Compliance Expertise: We understand the regulatory nuances of all MDSAP-participating countries and help align your systems accordingly.
- Custom-Fit Solutions: Our services are tailored to your unique organizational structure and product portfolio.
- End-to-End Support: From initial assessments to audit follow-ups, we provide full-spectrum assistance throughout the MDSAP journey.
- Quality-Focused Approach: Our commitment to quality helps position your products for long-term regulatory success and market acceptance.
Achieve Global Audit Readiness with Medral Global
Simplify your path to international regulatory compliance with a single, coordinated audit. Contact Medral Global today to begin your MDSAP preparation and unlock faster, more efficient access to multiple markets.