Top 5 Reasons to Use the Medical Device Single Audit Program

Tuesday, May 9, 2017 · 11:00 a.m. - 12:30 p.m. EDT

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. Sign up 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. Register now.

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Who Will Benefit

This session is a must-attend for quality and regulatory executives with –

  • Medical manufacturers
  • Manufacturing sites of finished medical devices
  • Devicemakers now selling into Canada and Japan
  • Manufacturer of combination products now selling into Australia
  • Organization intending to sell into Brazil
  • Manufacturer of high risk medical devices



Meet Your Presenter

Brian Ludovico

Executive Director, MDSAP Regulatory Certification
NSF Health Sciences

Mr. Ludovico has more than 20 years’ experience in quality and regulatory compliance, having worked for a well-known Notified Body/Certification Body (TUV Rheinland) where he managed the global CMDCAS and MDSAP programs.  He also was involved in the creation and review of key regulatory procedures and guidelines with the regulatory authorities.

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

Phone (703) 538-7600 | Fax (703) 538-7676 | Toll free (888) 838-5578 | Email

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