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Udemy - Iso 13485 - Medical Devices Qms Certification Masterclass |
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Torrent Details |
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- NAME
- Udemy - Iso 13485 - Medical Devices Qms Certification Masterclass.torrent
- CATEGORY
- Other
- INFOHASH
- e891aed43c2fa91c2f1befffad8e4d1d81d02418
- SIZE
- 2.4 GB in 50 files
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- Uploaded on 08-09-2022 by our crawler pet called "Spidey".
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Description |
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[ DevCourseWeb.com ] Iso 13485: Medical Devices Qms Certification Masterclass
If You Need More Stuff, kindly Visit and Support Us -->> https://DevCourseWeb.com
Published 9/2022
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
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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We upload these learning materials for the people from all over the world, who have the talent and motivation to sharpen their skills/ knowledge but do not have the financial support to afford the materials. If you like this content and if you are truly in a position that you can actually buy the materials, then Please, we repeat, Please, Support Authors. They Deserve it! Because always remember, without "Them", you and we won't be here having this conversation. Think about it! Peace...
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Files in this torrent |
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| 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 | 65.4 MB |
 | ~Get Your Files Here !/Bonus Resources.txt | 386 B |
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