Introduction

    The importance of training courses is not only limited to professional life, as most of us think but training courses aim to transfer knowledge and practical experiences that enrich the skills of individuals and enhance their self-confidence, which contributes to the preparation of cadres which in turn contributes to the development and progress of institutions. Therefore, Strategic Vision Training Center aims to enhance the skills and experiences of individuals through the strongest training programs to keep pace with every development in the labor market.

Objective

• Implementation of the individual audit program for medical devices
• The five-day Medical Device Audit Program (MDSAP) implementation course is for medical device manufacturers who wish to audit only once for compliance with regulatory and quality requirements.
• From multiple regulatory authorities. This course provides management system practitioners with the knowledge and skills to implement an ISO 13485:2016 Quality Management System that meets the regulatory requirements of various medical device markets:

Who should attend?

• The professionals involved in the ISO 13485:2016 management system plan to continue placing the devices on the market
• Support organizations to maintain effective compliance with the ISO 13485:2016 Quality Management System while embracing relevant jurisdiction imperatives within countries participating in the MDSAP Strategic Action Plan
• However, MDSAP differs from the ISO 13485:2016 standard audit, by its regulatory audit approach, nonconformance classification and audit report processing;

Course content:

• What is the Medical Device Audit Program (MDSAP) and why was it developed;
• what regulatory authorities are involved in the MDSAP program;
• The basics behind the MDSAP audit model and accompanying guidelines;
• The structure and scope of the MDSAP audit program, audit operations and their interrelationships;
• Differences between MDSAP and alternative QMS audits, enhancing your existing audit skills and being prepared to support effective MDSAP audits;
• discovery of MDSAP documents and correct regional word usage as well as reporting and non-conformance classification;
• Arranging time for MDSAP audits and using audit reports