Note: This webinar has been rescheduled from Oct. 13, 2021 to Nov. 11, 2021.

For devicemakers hoping to enter the global market, the Medical Device Single Audit Program (MDSAP) is a must.

MDSAP success can get your devices to market faster and it precludes being subject to routine FDA inspections, leading to a much less stressful relationship with the FDA.

If the FDA or ISO audit is what you’re used to, this webinar — filled with the latest developments, best practices and tips — is your ticket to MDSAP success.

Connie Hoy of Hoy & Associates Regulatory Consulting will cover all of this, so you can reap the benefits. Having successfully led multiple companies through the MDSAP preparation and audit process — and having been part of the pilot program — she’ll share lessons learned and the latest insights into what you must know and do to obtain certification.

Webinar Takeaways:

  • How to prepare successfully using the MDSAP Companion Document
  • How to ensure your quality system completely covers specific country requirements
  • What to expect in the audit’s registration review portion
  • How the MDSAP audit is conducted and how differs from an FDA inspection or ISO audit
  • What the grading system for nonconforming really means
  • Which specific areas of emphasis are different in the MDSAP audit from an ISO audit
  • What to expect when conducting internal audits under MDSAP

Pass your next MDSAP audit with the practical, must-know information you’ll take away from this webinar.

Who Will Benefit:

  • Regulatory and quality professionals involved in managing external quality audits