One Audit. Multiple Markets. Complete Confidence
MDSAP Certification Process – Global Compliance Made Easy
The Medical Device Single Audit Program (MDSAP) is a global initiative that allows a single regulatory audit to satisfy the requirements of multiple authorities, including the USA (FDA), Canada (Health Canada), Japan (PMDA), Brazil (ANVISA), and Australia (TGA). For manufacturers aiming to expand globally, MDSAP certification streamlines compliance while reducing the burden of multiple audits.
At Reghelps, we offer complete MDSAP consulting services—from QMS alignment and gap analysis to audit readiness and post-audit corrective action. Our experts ensure your organization is well-prepared, compliant, and confident through every step of the MDSAP certification journey.
Our MDSAP Consulting Approach for Medical Device Manufacturers
Navigating the Medical Device Single Audit Program (MDSAP) can be complex, especially when targeting multiple markets like the USA, Canada, Australia, Japan, and Brazil. At Reghelps, our MDSAP consultants provide tailored support to help you meet the stringent requirements of participating regulatory authorities.
We work closely with your quality and regulatory teams to ensure your QMS aligns with ISO 13485 and country-specific regulations, helping you pass audits with confidence and speed.
service related FAQ’s
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
