MDSAP – a global approach

Attend this onsite training to learn how to plan perform and report internal MDSAP audits as well as best practice and tools how to be prepared to undergo or perform MDSAP audits. It covers the requirements MDSAP place on a Quality Management System as well as the relationship between MDSAP, ISO13485:2016 and national regulatory requirements.

Course description

Introduction to MDSAP

• How to document and grade non-conformities under MDSAP
• Differences in how MDSAP Audits are performed in relation to device risk class and the size of the organization.

How do I best perform “Task Based Auditing”, using the MDSAP Audit approach of:

• Management
• Device Marketing Authorization and Facility Registration
• Measurement, Analysis and Improvement
• Medical Device Adverse Events and Advisory Notices Reporting
• Design and Development
• Production and Service Controls,
• Purchasing

For each task, we will explain and discuss:

• Which parts of a 13485-quality system are impacted by national regulatory requirements and need to become MDSAP compliant
• How to apply a risk-based audit approach and still cover all aspects of MDSAP

After this 2 day onsite course you will be better equipped to tackle the questions above. We’ll walk you through the key MDSAP requirements on the Medical Device quality management systems and provide you with tools to perform an efficient MDSAP gap analysis of your quality system. The relationship between ISO13485:2016 and MDSAP will be discussed, and requirements not covered by the standard pointed out.

The requirements posed on the legal manufacturer will be explained, and how to define and document relationships to other parties, such as the NB, subcontractors and suppliers.
Finally, we will cover how the participating countries make use of MDSAP audit outcome in their evaluation of devices and manufacturers.

Course outline

In this course you will learn how to:

• Identify and implement MDSAP regulatory requirements not covered by ISO13485:2016
• Understand aspects of ISO13485 that are crucial to fulfil the MDSAP QMS requirements.
• Be fully equipped to audit your internal quality management system against MDSAP.

Learning objectives

Completion of this course will give you the knowledge needed to 1) assess your current quality management system for MDSAP compliance and 2) plan and perform an internal MDSAP-audit. Participants will receive a Certificate of completion.

Who should attend

The course is suitable for persons involved in, or responsible for the operation or audit of a Quality Management System for medical devices who need to perform internal audits against MDSAP, or prepare the organization for upcoming MDSAP audits.

Prerequisites

• You should have good knowledge of medical device quality system from working with eg.  EU directives/regulations, 21CFR820, ISO13485.
• You should have at least 2 years of experience from the medical device industry

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