What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a certification program for the Quality Management System (QMS) of manufacturers that wish to sell medical devices to the following MDSAP participating countries: USA, Australia, Japan, Brazil, and Canada.
Initiated by the International Medical Device Regulators Forum (IMDRF), MDSAP intends to create a consolidated process for maintaining the safety and quality of medical devices by manufacturers that meet QMS international standards (ISO 13485:2016) and comply with the requirements of Regulatory Authorities (RA) of participating countries.
What are MDSAP audit checklists?
MDSAP audit checklists are tools used by quality managers to determine if the manufacturer’s QMS meets the requirements of ISO 13485:2016 and that of Regulatory Authorities. MDSAP audit checklists help quality managers determine the readiness of medical device manufacturers for MDSAP certification by recognized third-party Auditing Organizations (AO).
This article briefly discusses (1) the steps in working towards MDSAP certification; (2) technology to help ensure that implemented QMS meets the requirements of ISO 13485:2016 and of RAs; and (3) free MDSAP audit checklists.
Click here to browse and download the best MDSAP audit checklists
Technological Solution to the Challenges of MDSAP Certification
Working towards MDSAP certification can be costly and time-consuming, especially for manufacturers reliant on paper-based audits. Time spent on documentation of audits, reporting, and filing of records can be better spent working on gaps discovered and improving QMS to get certified for MDSAP. iAuditor, the world’s most powerful auditing app and software, can help manufacturers meet ISO 13485 and RA requirements and maintain the quality and safety of medical devices. Solve the challenges of MDSAP certification by doing the following:
- ✔ Create mobile-ready MDSAP checklists.
- ✔ Empower teams to proactively conduct efficient monitoring procedures and analysis using a smartphone or tablet.
- ✔ Save time with the iAuditor mobile app by generating comprehensive reports as internal quality officers finish audits.
- ✔ Secure all reports online and automatically share it with members of your organization. Preview a sample web and PDF report.
- ✔ Use for free with small teams. Unlimited reports and storage for premium accounts.