Medical Device Single Audit Program (MDSAP)
25+ years of experience as compliance partner
Are you looking to streamline your medical device auditing process across multiple regulatory jurisdictions? The Medical Device Single Audit Program (MDSAP) offers a solution that can save you time, reduce costs, and simplify your regulatory compliance journey. This program can benefit your organization with the support of our experienced compliance partners.
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Understanding MDSAP: a comprehensive overview
The Medical Device Single Audit Program represents a unique initiative that allows medical device manufacturers to undergo a single regulatory audit that satisfies multiple regulatory authorities. Instead of dealing with separate audits for different markets, MDSAP provides a unified approach to quality management system assessments.
Key participating regulatory authorities in MDSAP
The program brings together some of the world’s most respected regulatory bodies, creating a harmonized approach to medical device quality system audits:
- U.S. Food and Drug Administration (FDA)
- Health Canada
- Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
- Brazil’s National Health Surveillance Agency (ANVISA)
- Australia’s Therapeutic Goods Administration (TGA)
Benefits of MDSAP implementation
Implementing MDSAP can transform your approach to regulatory compliance. Here are the key advantages that manufacturers can expect:
- Reduced audit burden through a single harmonized audit process
- Cost-effective compliance management
- Streamlined international market access
- Consistent quality system evaluation
- Enhanced regulatory efficiency
- Improved time-to-market for new products
MDSAP audit process and requirements
The MDSAP audit follows a structured approach that evaluates your quality management system against ISO 13485:2016 requirements and participating regulatory authorities’ specific requirements. The audit process includes:
Primary focus areas
During MDSAP audit process your quality management system will be thoroughly evaluated across these essential aspects of medical device manufacturing:
- Management System
- Device Design and Development
- Production and Process Controls
- Corrective and Preventive Actions (CAPA)
- Purchasing Controls
- Medical Device Adverse Events and Advisory Notices
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Why choose Certification Experts for your MDSAP journey?
With over 25 years of experience in product compliance and more than 2,000 satisfied clients, Certification Experts understands the complexities of medical device certification. As your full service compliance partner, we provide:
Comprehensive support services
Our expert team delivers end-to-end support to ensure your successful MDSAP certification:
- Gap analysis of your current quality management system
- Preparation assistance for MDSAP audits
- Documentation review and optimization
- Training and consultation
- Post-audit support and maintenance guidance
MDSAP Implementation Timeline
The implementation of MDSAP typically involves several key phases:
1. Initial assessment and planning
- Evaluation of current quality management system
- Gap analysis against MDSAP requirements
- Development of implementation strategy
2. Documentation and process updates
- Quality manual revision
- Standard operating procedures development
- Record-keeping system enhancement
3. Internal audit and training
- Staff training on updated procedures
- Internal audit execution
- Corrective actions implementation
4. Official MDSAP audit
- Initial certification audit
- Surveillance audits
- Re-certification audit
Expert support throughout your compliance journey
Navigating the complexities of medical device compliance requires expert guidance and support. Our team at Certification Experts specializes in medical device compliance:
- 25+ years of experience
- Fullservice Compliance Partner
- 15+ experts
Get started with MDSAP today
Implementing the Medical Device Single Audit Program is a significant step toward efficient regulatory compliance. With Certification Experts as your partner, you can confidently navigate the certification process and access international markets with your medical devices.
Contact our experts today to begin your MDSAP journey and discover how we can help streamline your medical device certification process.
All the answers you might need!
Currently, MDSAP is recognized by five major regulatory authorities: the United States (FDA), Canada (Health Canada), Japan (PMDA), Brazil (ANVISA), and Australia (TGA). Health Canada is the only authority that has made MDSAP certification mandatory for medical device manufacturers.
ISO 13485 is a quality management system standard specifically for medical devices, while MDSAP is an audit program that combines ISO 13485 requirements with specific regulatory requirements from participating countries. MDSAP uses ISO 13485 as a foundation and adds country-specific requirements.
MDSAP stands for the Medical Device Single Audit Program, this is a harmonized approach to auditing and monitoring medical device manufacturing that allows a single audit to satisfy the requirements of multiple regulatory jurisdictions. It streamlines the MDSAP certification process and reduces the need for multiple country-specific audits.
MDSAP audits are conducted by Auditing Organizations (AOs) that have been authorized by the participating regulatory authorities. These organizations must demonstrate extensive expertise in medical device quality system auditing and maintain specific qualifications to perform MDSAP audits.
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