QMS for Medical Devices.pptx
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This document provides an overview of quality management systems for medical devices. It discusses ISO 13485, the international quality standard for medical device quality management systems. It outlines the pathway for setting up a quality management system that is compliant with ISO 13485 and applicable regulations. This includes planning the system, documenting policies and procedures, management reviews, and third party audits. The document also discusses standards and regulations from organizations like the FDA, EU, and Health Canada. It covers the certification process for quality management systems and medical devices. Finally, it discusses how technology can be leveraged to support quality management systems.
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It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
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LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
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Auditee's Conduct
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Interacting with Auditors: Don'tsProcess Validation & Verification (V&V) for Medical Devices
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(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
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Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
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This document provides an overview and agenda for a training on the Canadian Medical Devices Conformity Assessment System (CMDCAS). The training will cover ISO 13485 quality management system audits performed by Health Canada recognized registrars, certificate requirements, and audit report content. It will also review specific CMDCAS requirements, the transition to ISO 13485:2016 and the Medical Device Single Audit Program. The objective is to help participants understand how to incorporate CMDCAS into their quality management system documentation and prepare for an audit.
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The document discusses key concepts related to good laboratory practices including Good Manufacturing Practice (GLP), Good Laboratory Practice (GLP), the US FDA rules for GLP, OECD Guidelines for the Testing of Chemicals, ISO 9000 quality management standards, total quality management (TQM), quality review and documentation, validations, and process validation. GLP and ISO 9000 establish standards and guidelines to ensure uniformity, consistency, reliability, and quality in laboratory studies and testing. The US FDA and OECD provide specific rules and guidelines for GLP compliance. Validations are required to demonstrate equipment, facilities, and processes operate as intended to maintain compliance.
PECB Webinar: Overview of ISO 13485 - Medical Devices
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• In brief how ISO 13485 & ISO 9001 correlate
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Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
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Pkqa iso 17025 requirements
The document provides a history of accreditation in the UK, beginning with the British Calibration Service established in 1966. It later merged with another organization to form the National Measurement Accreditation Service in 1985, which was renamed the UK Accreditation Service in 1995. The document also defines accreditation and certification, and explains that accreditation evaluates a laboratory's technical competence according to ISO/IEC 17025. It provides an overview of the requirements for laboratories to achieve and maintain accreditation.
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• New directions for QMS and regulatory audits
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This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
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Looking for help to simplify your compliance with ISO 13485:2016? Get a QMS Audit checklist here: https://www.greenlight.guru/qms-audit-checklist
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
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From Food Safety in the 21st Century Marketplace: Best Practices Throughout the Supply Chain, http://www.restaurant.org/events/foodsafety.
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Pharmi Med Ltd is a consultancy firm that provides a variety of quality management, regulatory, and validation services for medical device and pharmaceutical companies. This includes helping companies establish quality management systems, obtain regulatory approval, conduct audits, and validate processes. The firm aims to be a one-stop solution for ensuring that clients' medical products meet industry standards and are approved for sale in target markets.
Pharmi Med Ltd Brochure
Pharmi Med Ltd is a consultancy firm that provides a variety of quality management, regulatory, and validation services for medical device and pharmaceutical companies. This includes helping companies establish quality management systems, obtain regulatory approval, conduct audits, and validate processes. The firm aims to be a one-stop solution for ensuring medical devices are approved for sale in target markets. It also provides templates and documentation to help clients become compliant more efficiently.
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2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
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选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
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【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
按照学校原版(QU文凭证书)皇后大学毕业证快速办理
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【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
一比一原版(Adelaide文凭证书)阿德莱德大学毕业证如何办理
学校原版办理海外认证【微信:176555708】【(Adelaide毕业证书)阿德莱德大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
按照学校原版(UOL文凭证书)利物浦大学毕业证快速办理
一比一办理办理毕业证【微信:176555708】【(UOL毕业证书)利物浦大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
按照学校原版(UST文凭证书)圣托马斯大学毕业证快速办理
精仿办理本科毕业证【微信:176555708】【(UST毕业证书)圣托马斯大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
一比一原版(Greenwich文凭证书)格林威治大学毕业证如何办理
毕业原版【微信:176555708】【(Greenwich毕业证书)格林威治大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
按照学校原版(AU文凭证书)英国阿伯丁大学毕业证快速办理
出售毕业典礼【微信:176555708】【(AU毕业证书)英国阿伯丁大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
Building a Raspberry Pi Robot with Dot NET 8, Blazor and SignalR
In this session delivered at NDC Oslo 2024, I talk about how you can control a 3D printed Robot Arm with a Raspberry Pi, .NET 8, Blazor and SignalR.
I also show how you can use a Unity app on an Meta Quest 3 to control the arm VR too.
You can find the GitHub repo and workshop instructions here;
https://bit.ly/dotnetrobotgithub
按照学校原版(Columbia文凭证书)哥伦比亚大学毕业证快速办理
快速办理假学位证【微信:176555708】【(Columbia毕业证书)哥伦比亚大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
1比1复刻澳洲皇家墨尔本理工大学毕业证本科学位原版一模一样
原版一模一样【微信：741003700 】【澳洲皇家墨尔本理工大学毕业证本科学位】【微信：741003700 】学位证，留信认证（真实可查，永久存档）offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原海外各大学 Bachelor Diploma degree, Master Degree Diploma
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
一比一原版(UCSB毕业证)圣塔芭芭拉社区大学毕业证如何办理
UCSB毕业证文凭证书【微信95270640】☀《圣塔芭芭拉社区大学毕业证购买》Q微信95270640《UCSB毕业证可查真实》文凭、本科、硕士、研究生学历都可以做,留信认证的作用：
1：该专业认证可证明留学生真实留学身份。
2：同时对留学生所学专业等级给予评定。
3：国家专业人才认证中心颁发入库证书
4：这个入网证书并且可以归档到地方
5：凡是获得留信网入网的信息将会逐步更新到个人身份内，将在网内查询个人身份证信息后，同步读取人才网入库信息。
6：个人职称评审加20分。
7：个人信誉贷款加10分。
8：在国家人才网主办的全国网络招聘大会中纳入资料，供国家500强等高端企业选择人才《文凭UCSB毕业证书原版制作UCSB成绩单》仿制UCSB毕业证成绩单圣塔芭芭拉社区大学学位证书pdf电子图》。
如果您是以下情况，我们都能竭诚为您解决实际问题：【公司采用定金+余款的付款流程，以最大化保障您的利益，让您放心无忧】
1、在校期间，因各种原因未能顺利毕业，拿不到官方毕业证+微信95270640
2、面对父母的压力，希望尽快拿到圣塔芭芭拉社区大学圣塔芭芭拉社区大学本科毕业证成绩单；
3、不清楚流程以及材料该如何准备圣塔芭芭拉社区大学圣塔芭芭拉社区大学本科毕业证成绩单；
4、回国时间很长，忘记办理；
5、回国马上就要找工作，办给用人单位看；
6、企事业单位必须要求办理的；
面向美国乔治城大学毕业留学生提供以下服务:
【★圣塔芭芭拉社区大学圣塔芭芭拉社区大学本科毕业证成绩单毕业证、成绩单等全套材料，从防伪到印刷，从水印到钢印烫金，与学校100%相同】
【★真实使馆认证（留学人员回国证明），使馆存档可通过大使馆查询确认】
【★真实教育部认证，教育部存档，教育部留服网站可查】
【★真实留信认证，留信网入库存档，可查圣塔芭芭拉社区大学圣塔芭芭拉社区大学本科毕业证成绩单】
我们从事工作十余年的有着丰富经验的业务顾问，熟悉海外各国大学的学制及教育体系，并且以挂科生解决毕业材料不全问题为基础，为客户量身定制1对1方案，未能毕业的回国留学生成功搭建回国顺利发展所需的桥梁。我们一直努力以高品质的教育为起点，以诚信、专业、高效、创新作为一切的行动宗旨，始终把“诚信为主、质量为本、客户第一”作为我们全部工作的出发点和归宿点。同时为海内外留学生提供大学毕业证购买、补办成绩单及各类分数修改等服务；归国认证方面，提供《留信网入库》申请、《国外学历学位认证》申请以及真实学籍办理等服务，帮助众多莘莘学子实现了一个又一个梦想。
专业服务，请勿犹豫联系我
如果您真实毕业回国，对于学历认证无从下手，请联系我，我们免费帮您递交
诚招代理：本公司诚聘当地代理人员，如果你有业余时间，或者你有同学朋友需要，有兴趣就请联系我
你赢我赢，共创双赢
你做代理，可以帮助圣塔芭芭拉社区大学同学朋友
你做代理，可以拯救圣塔芭芭拉社区大学失足青年
你做代理，可以挽救圣塔芭芭拉社区大学一个个人才
你做代理，你将是别人人生圣塔芭芭拉社区大学的转折点
你做代理，可以改变自己，改变他人，给他人和自己一个机会娃于是天天扳着手指算计着读书也格外刻苦无奈时间总过得太慢太慢每次父亲往家打电话山娃总抢着接听一个劲地提醒父亲别忘了正月说的话电话那头总会传来父亲嘿嘿的笑连连说记得记得但别忘了拿奖状进城啊考试一结束山娃就迫不及待地给父亲挂电话：爸我拿奖了三好学生接我进城吧父亲果然没有食言第二天就请假回家接山娃离开爷爷奶奶的那一刻山娃又伤心得泪如雨下宛如军人奔赴前线般难舍和悲壮卧空调大巴挤长蛇列车山娃发现车上挤满了乡
一比一原版(ANU文凭证书)澳大利亚国立大学毕业证如何办理
加急办理国外文凭【微信:176555708】【(ANU毕业证书)澳大利亚国立大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
Why is the AIS 140 standard Mandatory in India?
The Indian government has been working over the past few years to include elements of ITS in the transport sector. This standard ensures the optimal operation of the current transport infrastructure. It also increases the efficiency, safety, comfort, and quality of the system. That is why the government created the AIS-140 standard. Compliance with this standard means all vehicles used for public transit must have panic buttons and vehicle tracking modules installed. Nevertheless, in future in the standard protocol of AIS-140 you can expect fare collection and CCTV capabilities.
Get more information here: https://blog.watsoo.com/2023/12/27/all-about-prithvi-ais-140-gps-vehicle-tracker/
按照学校原版(UVic文凭证书)维多利亚大学毕业证快速办理
不能毕业办理文凭'毕业证购买'【微信:176555708】【(UVic毕业证书)维多利亚大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
按照学校原版(Greenwich文凭证书)格林威治大学毕业证快速办理
出售买大学文凭【微信:176555708】【(Greenwich毕业证书)格林威治大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
一比一原版(UQ文凭证书)昆士兰大学毕业证如何办理
毕业原版【微信:176555708】【(UQ毕业证书)昆士兰大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
按照学校原版(Westminster文凭证书)威斯敏斯特大学毕业证快速办理
加急购买办理毕业证【微信:176555708】【(Westminster毕业证书)威斯敏斯特大学毕业证】【微信:176555708】成绩单、外壳、offer、留信学历认证（永久存档真实可查）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【我们承诺采用的是学校原版纸张（纸质、底色、纹路），我们拥有全套进口原装设备，特殊工艺都是采用不同机器制作，仿真度基本可以达到100%，所有工艺效果都可提前给客户展示，不满意可以根据客户要求进行调整，直到满意为止！】
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信176555708】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信176555708】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
留信网服务项目：
1、留学生专业人才库服务（留信分析）
2、国（境）学习人员提供就业推荐信服务
3、留学人员区块链存储服务
→ 【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：客户在留信官方认证查询网站查询到认证通过结果后付款，不成功不收费！
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QMS for Medical Devices.pptx
- 1. Quality Management System For Medical Devices
- 2. Outline 2 Quality Management System (QMS) ISO 13485 QMS Setup Pathway QMS Activities Standards & Regulations QMS Certification Product Certification FDA & ISO 13485 Use of Technology in QMS
- 3. Quality Management System (QMS) 3 A formalized system that documents processes, procedures & responsibilities Helps achieve quality policy and objectives Coordinate and direct an organization’s activities Facilitate to meet customer and regulatory requirements Improves process effectiveness and efficiency consistently
- 4. What is ISO 13485? 4 An international quality system standard for Medical Devices QMS A stand-alone standard based on ISO 9001:2008 Latest version is 13485:2016, the only applicable version from March 2019 Companies manufacturing and selling medical devices should be certified to ISO 13485 and applicable regulations
- 5. QMS Setup Pathway 5 Planning of QMS Policy Documentation Quality Procedures and Requirements Procedures & Requirements for Operation of Processes Activities Pertaining to Applicable Regulations Management Reviews and Internal Audits MDSAP Audit
- 6. QMS Activities 6 QMS Plans Documentation & Controls Change Management Design Controls Risk Management Internal Audit Deviation Management Clinical Evaluation Documentation Commercialization Correspondence & Submissions with Regulators 3rd Party Audit Submissions for Device License
- 7. Standards & Regulations 7 ISO 13485 HC SOR 98/282 FDA CFR Part 820 EU MDR 2017/745 Safety & Security Risk Management Medical Electrical Equipment Product standards Software development Biological evaluation Clinical Investigations Other product / process standards as applicable
- 8. QMS Certification 8 MDSAP- Medical Device Single Audit Program 2 stage audit process • 1st Stage – Readiness Audit – 1.5 days • 2nd Stage – Conformity Assessment Audit – 3.5 days • Conducted by 3rd party registrars (Notified Bodies) MDSAP participants – USA, Canada, Brazil, Japan & Australia European Union – Currently an observer
- 9. Product Certification 9 In Canada – Submit application for Medical Device Licence (MDL) along with your MDSAP certificate In the US – Apply for Establishment Registration (Title 21CFR Part 807) Provide FDA Premarket submission number ( 510(k), De Novo, PMA, etc.) In Europe – CE Marking certificate for device & ISO 13485 Certificate for QMS – Prepare “Declaration of Conformity”
- 10. FDA vis-à-vis ISO 13485 10 FDA transitioning to ISO 13485-like QMS Deadline for feedback from industry and public ended 24-May-22 QMSR- The new harmonized regulation proposed by FDA which aligns with 13485 clauses and additional FDA requirements
- 11. Technology that compliments 11 Paper-based QMS system has become redundant QMS has transitioned to eQMS or higher PDM/PLM compliments eQMS in faster product launch
- 12. 12 Questions?