MDSAP Audit Essentials

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.

LEARNING OBJECTIVES

  • 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

WHO NEEDS THIS COURSE?

  • 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

CLASS AGENDA

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

CERTIFICATION

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

Recent Popular Searches

Auditing Training Consulting ISO Training Maritime Consulting ISO Consulting ISO Lead Auditor Training Quality Management Interntional Inc "AS9100 Training " "AS9110 Training " "AS9100 Lead Auditor Training " "AS9110 Lead Auditor Training " "Auditing Services " "Auditing Firms " "Auditor Training " "ISO 9001 " "ISO 9001 Lead Auditor Training " Maritime Cyber Security ISO 14001 Lead Auditor Corporate Training Solutions IATF 16949 Internal Auditor training Course IATF 16949 Lead Auditor Course ISO Management Systems - Workshop ISM Auditor training course ISO 13485 Lead Auditor Training ISO 14001:2015 Executive Overview Course ISO 14001:2015 Lead Auditor Training Course ISO 14001:2015 Training Course ISO 17025 Lead Auditor Training Course ISO 22000 Lead Auditor Course ISO 22301 LEAD AUDITOR TRAINING Course ISO 28000 Auditor Training Course ISO 45001:2018 Auditor Training ISO 9001 Executive Overview Course ISO 9001:2015 Lead Auditor Training course ISO/IEC 20000 LEAD AUDITOR TRAINING ISPS Auditor Training MARITIME CYBER SECURITY AUDITOR TRAINING Maritime Solutions Online ISO Training Responsible Care Lead Auditor training with RCMS RC14001 at QMII RCA / Problem Solving Workshop Subchapter M Compliance Subchapter M Compliance TSMS or USCG TPECS Modules VSO/CSO/PFSO Training Course