Course details
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a "PECB Certified ISO 13485 Lead Implementer" credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an ; Updated on 01 May, 2019
Eligibility / Requirements
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Course Location
About Fox Star Management Development and Training
VISION
Regional leadership in Organizational Development, Compliance and Accreditation of individual and Enterprises.
MISSION
Provision Best-In-Class services in field of Organizational Development, Individuals Professional Qualification, and Enterprises, and accreditation in accordance with the latest international standards and practices.
CORE VALUES
• Commitment to Quality
• Honesty
• Excellence
GOALS and OBJECTIVES
1. Promote for values, and principles of Organizational Development by providing Management Consultations that ensure compliance of enterprises with international standards and best practices, and spread the culture of Excellence in Governmental service at the regional level.
2. Provision of Management and Technical training courses to develop enterprise's’ staff skills and to support the career path development in a way to qualify them for international accreditations according to the latest international standards and specifications.
3. Provision assessment and accreditation services to individuals and enterprises in accordance with international standards.
4. Train and qualify security and military personnel in their areas of competence to assure it remains in align with modern standards in the field of security and military.
Quality Excellence and Improvement Related Questions
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