Medical Device Single Audit Program (MDSAP)

One-day training on the Medical Device Single Audit Program (MDSAP) to provide Medical Device Manufactures an overview of the MDSAP process, MDSAP documentation, MDSAP Audits, and how to prepare for participating in the MDSAP program for Canada, Brazil, Australia, Japan and the United States.

Who Should Attend: Quality and Regulatory professionals including individuals in the Medical Device Industry who need to understand the MDSAP Program or who may have a responsibility to facilitate, prepare for or participate in MDSAP Audits.

Topics Include:

• Overview of MDSAP
• Responsibilities and authorities of Regulatory Agencies, The Regulatory Authority Council, Auditing Organizations and Medical Device Manufacturers
• MDSAP documentation
• MDSAP and ISO 13485:2016
• MDSAP Audit Model
  • Audit Time Determination Model
• MDSAP Audit Types
  • Initial
    • Stage 1
    • Stage 2
  • Surveillance Audits
  • Re-audits (Recertification)
  • Special Audits
  • Audits Conducted by Regulatory Agencies
  • Unannounced Audits
• MDSAP Audit Chapters (The auditors script and guidance)
  • Management
  • Device marketing authorization and facility registration
  • Measurement, analysis and improvement
  • Medical device adverse events and advisory notice reporting
  • Design and Development
  • Production and service controls
  • Purchasing
• Auditing of:
  • Linked processes
  • Risk based requirements
• • Country specific Regulatory requirements
• Post Audit process and documentation
  •  Nonconformity grading matrix
  • Audit report
  • Regulatory Authority notification
• Benefits and Challenges of participating in MDSAP
• Organizational readiness and alignment including
  • Internal audit process
  • Preparation for and organizational readiness

8 Hours

Contact Information

Email
paulette@pyyoungassociates.com

Phone
1 (650) 967-2700

Address
P.O. Box 2103
Sunnyvale, CA 94087-0103