Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) streamlines regulatory compliance for medical device manufacturers by enabling a single audit to meet the requirements of five participating regulatory authorities: the US FDA, Health Canada, Brazil's ANVISA, Japan's MHLW/PMDA, and Australia's TGA. This program reduces the audit burden on companies by replacing multiple country-specific audits and inspections with one comprehensive audit. Notably, Health Canada has mandated MDSAP certification since January 2019 for market access.
Achieve MDSAP Certification
Achieving Medical Device Single Audit Program (MDSAP) certification can be overwhelming, but achieving compliance doesn’t have to be. Our MDSAP service offers a practical approach to meet the regulatory requirements across the MDSAP jurisdictions: U.S., Canada, Japan, Brazil, and Australia — helping you reduce costs and time-to-market. From preparing for audits to ensuring ongoing compliance, our team of experienced consultants will guide you through every step, allowing you to focus on what matters most: bringing your device to those who need it..jpg.ashx?preset=content)
Key Features and Benefits
- Multi-Market Compliance, One Audit: Meet regulatory requirements of multiple jurisdictions with a single, integrated audit.
- Expert Guidance Every Step of the Way: From audit preparation to corrective action planning, our experts offer hands-on support to ensure your compliance journey is smooth and successful.
- Reduce Costly Delays and Non-Compliance Risks: Our proactive approach mitigates risks that could lead to delays, fines, or lost market opportunities.
- Tailored Solutions for Unique Business Needs: Get custom strategies designed for your specific devices, ensuring you meet regulatory requirements without unnecessary complexity.
- Continuous Compliance Support: We provide ongoing guidance and support beyond the audit, so you’re always ready for future audits and regulatory changes.
How Qserve can Assist
We offer MDSAP support during all stages of your MDSAP journey:
MDSAP Gap Assessment and Implementation Support
Qserve offers MDSAP Gap Assessments to help manufacturers understand the gaps in their quality management system with the requirements of ISO 13485 and the jurisdictional regulatory requirements.
Our experienced consultants provide also guidance on implementing these requirements within your quality management system and ensure you are well-prepared for the review and audit by your Auditing Organization.
MDSAP Mock Audits
Qserve offers MDSAP Mock Audits to help manufacturers prepare effectively. Qserve's Mock Audits will help you determine your state of readiness for an MDSAP audit by your Auditing Organization.
Qserve’s MDSAP Mock Audit is designed to assess your readiness for an MDSAP audit by evaluating your current compliance level and determining your organizational audit maturity. Using the same approach as Auditing Organizations, we simulate the formal MDSAP audit process and calculate your MDSAP audit grading. Unlike the Auditing Organization or a Regulatory Authority, Qserve can compare your quality management system to industry best practices and provide tailored recommendations for improvement.
As a follow-up of the Mock Audit, you can leverage Qserve’s expert support, which includes implementing quality management system improvements or providing additional MDSAP training. This comprehensive preparation ensures you are well-positioned to succeed in the formal MDSAP audit.
MDSAP Training
Qserve offers comprehensive MDSAP training to equip your team with the knowledge and skills needed to understand the Medical Device Single Audit Program requirements. Our training sessions cover the core principles of MDSAP, the audit process and approach, and the specific expectations of participating regulatory authorities. Through interactive sessions, practical examples, and tailored guidance, we ensure your team understands how to align your quality management system with MDSAP. Whether you're new to MDSAP or looking to deepen your expertise, Qserve's training provides the foundation for streamlined compliance and successful audits.
Visit Qserve's Training Center
MDSAP++
In addition to the implementation, auditing, and training concerning the regulatory requirements of the authorities participating in MDSAP, Qserve can also support you in leveraging quality management systems and GMP requirements of other major markets including the requirements of China, Taiwan, and South Korea — increasing the effectivity and efficiency of your compliance program.