Medical Device Single Audit Program (MDSAP)
A single audit of a medical device manufacturer’s QMS to meet regulatory requirements for the USA, Canada, Brazil, Japan, and Australia.
The Medical Device Single Audit Program (MDSAP)
It is a regulatory initiative that allows a single audit of a medical device manufacturer’s Quality Management System (QMS) to satisfy the regulatory requirements of multiple countries.
MDSAP simplifies the regulatory audit process by harmonizing standards, saving time and resources for manufacturers while ensuring compliance with each country’s unique regulations.
MDSAP audits are conducted by third-party auditing organizations authorized by participating regulatory authorities.
Benefits of (MDASP)
Medical Device Single Audit Program
Streamlined Compliance
One audit satisfies multiple regulatory bodies, reducing duplication.
Improved Market Access
Achieving MDSAP certification signals strong compliance and opens doors to global markets.
Cost and Time Savings
Fewer audits mean lower expenses and faster time-to-market for medical devices.
Risk Mitigation
Comprehensive audits help manufacturers identify and address potential issues proactively.
Take the First Step
Stay compliant and competitive in the medical device market.
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