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Top 5 Reasons to Use the Medical Device Single Audit Program
The Medical Device Single Audit Program, or MDSAP, is skyrocketing in popularity as devicemakers discover its many advantages. Already 229 devicemakers have adopted it — 72 in this quarter alone.
CDRH now accepts MDSAP audits in place of routine device inspections. Regulators in Canada, Australia, Japan and Brazil also are in various stages of implementation, and other international regulators are taking a hard look.
Devicemakers are fast realizing that single audits can:
- Save time, money and hassles by replacing multiple audits with just one ...
- Coordinate with regulators internationally, easing the compliance burden.
Start using the MDSAP in your organization. Order now for this crash course.
In just 90 minutes, Brian Ludovico of MDSAP Regulatory Certification will show you how to begin your MDSAP participation.
You’ll discover how to:
- Substitute MDSAP audit reports for FDA routine inspections
- Identify international regulators now participating in the MDSAP pilot process or soon to be
- Learn how others are faring in the program to date
- Understand how the MDSAP affects pre- and post-market approval applications, device classification and ISO 13485 compliance
And that’s not all. Learn which auditing organizations are reliable and consistent ... find the documents you need to prepare for the MDSAP audit program ... plus much more!
Wish routine device audits would just go away? They have, for 229 of your fellow devicemakers ... and they can for you too. Order now.