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TORRENT DETAILS
Udemy - Iso 13485 - Medical Devices Qms Certification Masterclass
TORRENT SUMMARY
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Language: English | Size: 2.44 GB | Duration: 9h 1m
Learn ISO 13485 from scratch for medical devices development, production, storage and distribution or installation
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 nstrate 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
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FILE LIST
Filename
Size
~Get Your Files Here !/1 - Introduction/1 - Introduction.mp4
53.2 MB
~Get Your Files Here !/2 - Scope of ISO13485 Standard/2 - General Scope.mp4
24.4 MB
~Get Your Files Here !/2 - Scope of ISO13485 Standard/3 - Application.mp4
46.2 MB
~Get Your Files Here !/3 - Terms and Definitions/4 - Terms and Definitions.mp4
13.7 MB
~Get Your Files Here !/4 - Quality Management System/5 - General Requirements.mp4
54.5 MB
~Get Your Files Here !/4 - Quality Management System/6 - Documentation Requirements.mp4
57.4 MB
~Get Your Files Here !/4 - Quality Management System/7 - Quality Manual.mp4
67.9 MB
~Get Your Files Here !/4 - Quality Management System/8 - Control of Documents.mp4
90.9 MB
~Get Your Files Here !/4 - Quality Management System/9 - Control of Records.mp4
64.9 MB
~Get Your Files Here !/5 - Management Responsibility/10 - Management Commitment Requirements.mp4
19 MB
~Get Your Files Here !/5 - Management Responsibility/11 - Customer Focus.mp4
10.4 MB
~Get Your Files Here !/5 - Management Responsibility/12 - Quality Policy.mp4
22.2 MB
~Get Your Files Here !/5 - Management Responsibility/13 - Planning.mp4
46.1 MB
~Get Your Files Here !/5 - Management Responsibility/14 - Responsibility and Authority.mp4
28.9 MB
~Get Your Files Here !/5 - Management Responsibility/15 - Management Reoresentative.mp4
17.4 MB
~Get Your Files Here !/5 - Management Responsibility/16 - Internal Communication.mp4
24.9 MB
~Get Your Files Here !/5 - Management Responsibility/17 - General.mp4
22.3 MB
~Get Your Files Here !/5 - Management Responsibility/18 - Review Input.mp4
27.7 MB
~Get Your Files Here !/5 - Management Responsibility/19 - Review Output.mp4
34.7 MB
~Get Your Files Here !/6 - Resource Management/20 - Provision and Resources.mp4
20.9 MB
~Get Your Files Here !/6 - Resource Management/21 - Human Resource.mp4
11.9 MB
~Get Your Files Here !/6 - Resource Management/22 - Competence Awareness and Training.mp4
97.9 MB
~Get Your Files Here !/6 - Resource Management/23 - Infrastructure.mp4
82.1 MB
~Get Your Files Here !/6 - Resource Management/24 - Work Environment.mp4
46.5 MB
~Get Your Files Here !/6 - Resource Management/25 - Human Resources Health.mp4
88 MB
~Get Your Files Here !/7 - Product Realization/26 - Planing of Product Realization.mp4
41.8 MB
~Get Your Files Here !/7 - Product Realization/27 - Verification of the Product.mp4
63.1 MB
~Get Your Files Here !/7 - Product Realization/28 - Customer Related Processes.mp4
41.4 MB
~Get Your Files Here !/7 - Product Realization/29 - Review of Product Requirements.mp4
54.5 MB
~Get Your Files Here !/7 - Product Realization/30 - Customer Communication.mp4
89.7 MB
~Get Your Files Here !/7 - Product Realization/31 - Design and Development of Planning.mp4
63.8 MB
~Get Your Files Here !/7 - Product Realization/32 - Design and Development of Inputs.mp4
49.1 MB
~Get Your Files Here !/7 - Product Realization/33 - Design and Development Outputs.mp4
34.5 MB
~Get Your Files Here !/7 - Product Realization/34 - Design and Development of Review.mp4
45 MB
~Get Your Files Here !/7 - Product Realization/35 - Verification Requirements.mp4
17.3 MB
~Get Your Files Here !/7 - Product Realization/36 - Design and Development of Validation.mp4
94.9 MB
~Get Your Files Here !/7 - Product Realization/37 - Control of Design and Development Changes.mp4
55.8 MB
~Get Your Files Here !/7 - Product Realization/38 - Purchasing Process.mp4
93.2 MB
~Get Your Files Here !/7 - Product Realization/39 - Purchasing Information.mp4
47.1 MB
~Get Your Files Here !/7 - Product Realization/40 - Verification of Purchased Product.mp4
48.6 MB
~Get Your Files Here !/7 - Product Realization/41 - Control of Production and Service Provision.mp4
57.3 MB
~Get Your Files Here !/7 - Product Realization/42 - The Use of Monitoring and Measuring Devices.mp4
114.9 MB
~Get Your Files Here !/7 - Product Realization/43 - Control of Production and Specific Requirements.mp4
64.6 MB
~Get Your Files Here !/7 - Product Realization/44 - Installation Activities.mp4
76 MB
~Get Your Files Here !/7 - Product Realization/45 - Service Data Information and Report.mp4
37.9 MB
~Get Your Files Here !/7 - Product Realization/46 - Particular Requirements for Medical Devices.mp4
34.6 MB
~Get Your Files Here !/8 - Measurement Analysis and Improvement/47 - Measurement Analysis and Improvement.mp4
41.2 MB
~Get Your Files Here !/8 - Measurement Analysis and Improvement/48 - Monitoring and Measurement.mp4
96.2 MB
~Get Your Files Here !/8 - Measurement Analysis and Improvement/49 - Internal Audit.mp4
