MDSAP Program in a (large) Nutshell

The International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program (MDSAP) to encourage and support global convergence of regulatory systems, where possible. It seeks to strike a balance between the responsibilities of Regulatory Authorities to safeguard the health of their citizens as well as their obligations to avoid placing unnecessary burdens upon Auditing Organizations or the regulated industry. IMDRF Regulatory Authorities may add additional requirements beyond this document when their legislation requires such additions.This whitepaper is designed to help the lay manufacturer and others trying to understand the ‘jist’ and impact of this audit program on the future of regulated manufacturing world- wide.