MDSAP Audit Essentials

Learn the key differences between MDSAP and ISO 13485

& how to prepare for an MDSAP Audit.

Learn the requirements of MDSAP, what gets audited and how to prepare for an MDSAP audit.  This training (conducted as a workshop) is designed for staff in quality and regulatory functions in medical device, and combo-device companies. Learn in this 2-day MDSAP Audit Essentials training:

  • What MDSAP Certification is about and when to consider it vs. ISO 13485
  • Key differences between MDSAP and ISO 13485
  • What gets audited in an MDSAP audit, the expected duration
  • How to prepare for an MDSAP audit
  • The Key Processes and Elements within the same that auditors will examine

The workshop is conducted in a highly interactive approach with exercises and quizzes that enable the participants grasp the important topics. Because of our independence, participants can bring their SOPs and other documents for review with the workshop leader, thereby ensuring that the learnings can be applied to your work processes immediately. The instructor will work to answer your questions as best as possible.

  • MDSAP and its fit with your organization’s strategy / direction
  • What is MDSAP and how is it different from ISO 13485
  • Global reach of MDSAP and how it can benefit your company
  • The Essential Processes and Elements of the same that get audited
  • How to prepare for MDSAP
  • Duration and anticipated costs for an MDSAP audit
  • What parts of your business will be covered by MDSAP
  • The impact to Supply Chain – Upstream (your suppliers) and Downstream (your distributors) of your company
  • Tips on preparing / updating / upgrading your QMS and SOPs
  • The Grading System, rules and responses for addressing Non-conformities
  • Medical device professionals
  • Professionals from FDA regulated industries
  • Quality professionals
  • ISO Managers/Management Reps
  • Internal Auditors
  • Process owners
  • Systems professionals or people who want to understand how management systems work
  • Improvement Specialists
  • Leaders/managers/professionals in the Medical Device industry

This two-day agenda is provided as a guide. Sequence of topics may vary to suit the audience.

Day 1

  • Introduction and brief history of MDSAP
  • Countries applicable to and their level of acceptance
  • Entities in MDSAP and their Relationships
  • Auditing Organizations and their Roles
  • Impact to your company’s strategic direction and plans
  • Audit stages and what to expect in each
  • Preparing for each audit stage
  • MDSAP Audit Cycle
  • Other Audits that can happen
  • Auditing – The Seven Processes – overview

Day 2

  • Auditing – The Seven Processes (in detail)

    – Management (1st. Primary process)

    – Device Marketing Authorization and Facility Registration

    – Measurement Analysis and Improvement (2nd. Primary process)

    – Mock audit exercise and tips on how to create / update your SOPs / QMS

    – Medical Device Adverse Events and Advisory Notices Reporting

    – Design and Development (3rd. Primary process)

    – Production and Service Controls (4th. Primary process)

    – Purchasing

    – Mock audit exercise and tips on how to create / update your SOPs / QMS

  • Class Wrap Up
  • Non-conformity Grading and Escalation Rules

Attendees successfully completing the training provided receive a Certificate of Participation, which includes the number of training hours attended