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Understanding the Requirements of ISO 13485:2016 and International MDSAP Audit Model

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OMNEX is now offering QMS Training based on both ISO 13485:2016 and international Medical Device SingleAudit Program (MDSAP) requirements. The two-day training program focuses on international MDSAP and ISO 13485-compliant medical device requirements.

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge and skills to implement a QMS with ISO13485:2016 management system requirements in accordance with the new MDSAP Audit Model.

OMNEX’sUnderstanding MDSAP training course will teach students to plan, develop and implementa QMS in accordance with MDSAP and ISO 13485:2016 requirements.

Considering the ISO 13485:2016 management system requirements and various regulatory authorities’ compliance requirements around the world and the global supply chains involved, a comprehensive program likeOMNEX’s Understanding MDSAP Training is incredibly valuable. The course provides extensive practical training and hand-on exercises, which will help prepare medical device implementers to identify critical MDSAP requirements and set up a QMS to meet international regulatory requirements.

The course is designed for medical device professionals with responsibility for implementing, maintaining and preparing the QMS internal, supplier or corporate management systems. Quality directors, regulatory managers and professionals responsible for managing internal, corporate, supply chain or certificationresponsibilities may also benefit from thisunique training.

Upon completion the participants will be capable to effectively develop, implement and support a QMS to maintain compliance to ISO 13485 and jurisdiction requirements in the countries participating in the MDSAP program.

Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.

This course will help you:

  • Improve understandingof regulatory auditing
  • Improve competence for MDSAP development, implementation and maintenancea QMS that meet all MDSAP audit requirements.
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Participants will gain the knowledge and skills to:

  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit
  • Understand MDSAP and regulatory compliance
  • Understand MDSAP reporting and nonconformity grading methods
  • Determine MDSAP documentation requirements
  • Understand the seven MDSAP auditing process requirements
  • Analyze data sources and control interactions required during process audits
  • Use correct jurisdictional terminology

Who should attend?

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in MDSAP.

Recommended Training and/or Experience

Thorough understanding of ISO 13485:2016 with experience in auditing ISO 13485:2016 QMS.

How will I learn?

Our high impact accelerated learning approach that increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

Seminar Agenda

Day One

  • Introduction and Welcome
  • Chapter 1: MDSAP Background
  • Chapter 2:MDSAP Audit Structure
  • Chapter 3: Quality Management System
    • Written Exercise 1: Risk Management
  • Chapter 4:MDSAP Audit Model and Tasks
    • Management Processes
    • Device Marketing Authorization and Facility Registration
    • Measurement, Analysis and Improvement
    • Written Exercise 2a: Audit Scenarios

Day Two

  • Chapter 4: MDSAP Audit Model and Tasks (cont’d)
    • Medical Device Adverse Events & Advisory Notices Reporting
    • Design and Development
    • Production and Service Controls
    • Purchasing
    • Written Exercise 2b: Audit Scenarios
    • Understanding MDSAP Final Exam

Understanding the Requirements of ISO 13485:2016 and International MDSAP Audit Model

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