What you'll learn
Learn all ISO 13485 characteristics including the specific procedures, documentations, regulatory requirements and risk management
The role of ISO 13485 2016 in the United States and EU regulation system.
Learn the Active Implantable Medical Device Directive 90/385/EEC.
Understand realization of a medical device, with reference to various types of processes and products in the industry
ISO 9000:2000: Quality management systems
Supply chain management and activities of medical devices
Identifying and Implementing the Quality Management System for medical devices
Planning quality objectives of product realization
Learn Quality policy, Quality objectives, Realization process, Requirements and Effectiveness for medical device manufactoring
Master planning of the realization of the medical device and building a Quality Plan
Validation and Verification Activities
Evaluation criteria of design and development of medical devices
Building device history record (DHR) and device master record (DMR)
Control of production service and service provision
Requirements
No prior experience required
The course is suitable for everyone with desire to learn Medical Devices Quality Management
Description
This course is a complete step-by-step certification guide to ISO 13485. ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activitiesRequirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.Section 1 Scope: This section reviews the ISO 13485 Standard's aims and concepts and defines the scope of application of the standard to your quality management systemSection 2 Normative References: The meaning and purpose of the normative references is to indicate that terminology and nomenclature specified in this standard is not open for debate or an interpretive discussion.Section 3 Quality Management System: This section provides the general requirements and main principles of a quality management systems. This section is a foundation for self-evaluation of whether the organization's quality management system follows the general requirements.Section 4 Management Responsibility: This section lays out the requirements of top management regarding the quality management system. It specifies the principle that will construct the commitment of top managementSection 5 Resource Management: Resources are one of the foundation stones of the quality management system. The standard requires us to define, manage, and control our resources. The standard relates to three kinds of resources: human resources, infrastructures, and work environment. These are responsible for critical areas and scopes of the realization processes, especially when it comes to medical devices.Section 6 Product realization: The section initiates the master planning of the realization of the medical device and refers for the first time to the term "quality plan". Planning of this will cover the entire life cycle of the medical device.Section 7 Measurement Analysis and Improvement: The objective of the measuring processes is to collect, analyze, and report data that are relevant to the medical devices and realization processes. The analysis shall strive to support the processes and maintain the effectiveness of your quality management system, as well as the quality of the medical devices
Overview
Section 1: Introduction
Lecture 1 Introduction
Section 2: Scope of ISO13485 Standard
Lecture 2 General Scope
Lecture 3 Application
Section 3: Terms and Definitions
Lecture 4 Terms and Definitions
Section 4: Quality Management System
Lecture 5 General Requirements
Lecture 6 Documentation Requirements
Lecture 7 Quality Manual
Lecture 8 Control of Documents
Lecture 9 Control of Records
Section 5: Management Responsibility
Lecture 10 Management Commitment Requirements
Lecture 11 Customer Focus
Lecture 12 Quality Policy
Lecture 13 Planning
Lecture 14 Responsibility and Authority
Lecture 15 Management Reoresentative
Lecture 16 Internal Communication
Lecture 17 General
Lecture 18 Review Input
Lecture 19 Review Output
Section 6: Resource Management
Lecture 20 Provision and Resources
Lecture 21 Human Resource
Lecture 22 Competence, Awareness and Training
Lecture 23 Infrastructure
Lecture 24 Work Environment
Lecture 25 Human Resources Health
Section 7: Product Realization
Lecture 26 Planing of Product Realization
Lecture 27 Verification of the Product
Lecture 28 Customer Related Processes
Lecture 29 Review of Product Requirements
Lecture 30 Customer Communication
Lecture 31 Design and Development of Planning
Lecture 32 Design and Development of Inputs
Lecture 33 Design and Development Outputs
Lecture 34 Design and Development of Review
Lecture 35 Verification Requirements
Lecture 36 Design and Development of Validation
Lecture 37 Control of Design and Development Changes
Lecture 38 Purchasing Process
Lecture 39 Purchasing Information
Lecture 40 Verification of Purchased Product
Lecture 41 Control of Production and Service Provision
Lecture 42 The Use of Monitoring and Measuring Devices
Lecture 43 Control of Production and Specific Requirements
Lecture 44 Installation Activities
Lecture 45 Service Data Information and Report
Lecture 46 Particular Requirements for Medical Devices
Section 8: Measurement, Analysis and Improvement
Lecture 47 Measurement, Analysis and Improvement
Lecture 48 Monitoring and Measurement
Lecture 49 Internal Audit
Quality Assurance Specialists,Quality Assurance Engineers,Project Managers,Research and Development Professionals,Verification and Validation Professionals,Process Development Engineers,Business Owners looking to implement ISO 13458,Operation Professionals,Business Students and Graduates,Professionals working with in ISO 13485, QSR ISO 9001, 21 CFR 820,Six Sigma and Quality Control Professionals


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