10最好的医疗设备开发教程推荐

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特写 iPhone,显示 Udemy 应用程序和带笔记本的笔记本电脑有数以千计的在线课程和课程可以帮助您提高 医疗设备开发 技能并获得 医疗设备开发 证书。

在这篇博客文章中,我们的专家汇总了 10 个精选列表 最好的 医疗设备开发 课程, 现在在线提供的教程、培训计划、课程和认证。

我们只包括那些符合我们高质量标准的课程。我们花了很多时间和精力来为您收集这些。这些课程适合所有级别的初学者、中级学习者和专家。

以下是这些课程以及它们为您提供的内容!

10最好的医疗设备开发教程推荐

1. Practical Regulatory Affairs 2020 – US FDA Medical Devices 经过 Pubudi Silva Udemy课程 我们的最佳选择

A practical course discussing the US FDA Medical Device regulations for real-world situations

截至目前,超过 1384+ 人们已经注册了这门课程,而且已经结束了 454+ 评论.

课程内容
Introduction
FDA Scope and Code of Federal Regulations
Device Classification
FDA Regulatory Pathways
FDA Pre-Market Notification [510(k)]513(g) Mechanism
De Novo Submission
Pre-Market Approval (PMA)
FDA QSR and Post-Submission Requirements
Emergency Use Authorizations (EUA)
Final Tools

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2. Medical Device Regulation 2017/745 EU regulatory affairs. 经过 Martin Conneely Udemy课程

Understand regulations for medical devices in simple terms to gain market approval of a medical device in the EU.

截至目前,超过 1355+ 人们已经注册了这门课程,而且已经结束了 388+ 评论.

课程内容
Section 1 Introduction
Section 2 Economic Operators
Section 3 EUDAMED
Section 4 UDI/Registration
Section 5 Classification of medical devices
Section 6 Conformity assessment
Section 7 Sufficient Clinical Data
Section 8 Post market Surveillance
Section 9 Miscellaneous
Bonus Section

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3. Practical Regulatory Affairs 2020 – European Medical Devices 经过 Pubudi Silva Udemy课程

A practical course discussing the EU Medical Device Regulation (MDR) in real-world situations

截至目前,超过 1189+ 人们已经注册了这门课程,而且已经结束了 466+ 评论.

课程内容
Introduction
Directives to Regulations
EU Regulatory Pathway
EU Regulatory Submissions – Quality Management Systems
EU Regulatory Submissions – Technical Documentation
EU Regulatory Pathway – Final Steps
Final Tools

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4. Medical Device Regulation (MDR): Intro for Device Designers 经过 James Holmes Udemy课程

An introduction to the EU’s Medical Device Regulation (MDR) for those involved in developing medical devices

截至目前,超过 925+ 人们已经注册了这门课程,而且已经结束了 231+ 评论.

课程内容
“Course Overview
Overview and General Requirements
Safety & Performance Requirements, Clinical Evaluation & Technical Documentation
Focus on…”

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5. Advanced Medical Device Development 经过 Josh Simon Udemy课程

“Development of medical devices with an established design through manufacturing, clinical, and regulatory hurtles.”

截至目前,超过 220+ 人们已经注册了这门课程,而且已经结束了 53+ 评论.

课程内容
“Introduction to Advanced Medical Device Development
EU Regulatory Basics
The Design History File – In depth
Device Documentation: DHR, DMR, SOP’s, ECO
Process Validation and Process Risk
Quality Systems Management
Clinical Trials for Medical Devices
The Product Life Cycle & Product Management”

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6. IVDR 2017 746 regulatory affairs: Learn EU compliance 经过 Martin Conneely Udemy课程

Understand regulations for Invitro diagnostic medical devices in simple terms to gain EU market approval

截至目前,超过 215+ 人们已经注册了这门课程,而且已经结束了 48+ 评论.

课程内容
Section 1.0 Introduction
Section 2 Economic Operators
Section 3.0 EUDAMED
Section 4.0 UDI/Registration
Section 5.0 Classification of an In Vitro diagnostic medical device
Section 6.0 Conformity Assessment
Section 7.0 Sufficient Clinical Evidence
Section 8.0 Post Market Surveillance
Section 9.0 Miscellaneous
Extra Content
Additional

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7. Medical Device Development 经过 Josh Simon Udemy课程

A basic level primer for those starting their careers developing medical devices in a heavily regulated environment.

截至目前,超过 214+ 人们已经注册了这门课程,而且已经结束了 76+ 评论.

课程内容
“Introduction to Medical Device Development – Academia vs. Industry
Project Management for Medical Devices – How Corporations Manage Projects
Pre-clinical Device Development – Research projects
Regulatory Basics for Medical Devices
Quality Control and Quality Assurance
Business 101 – What makes corporations tick and research labs tock
Marketing medical devices, and the basics of sales forces
Clinical Research
Design Controls 101
Risk Analysis for Medical Devices
Organizational Development in Device Companies
Consultants and Some Legal Basics”

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8. 21 CFR Part 820 (Medical Device QSR) – Practice Exam 经过 “Exoexcellence Training Resources, Waqas Imam” Udemy课程

“21 CFR Part 820 Exam – Self Assessment Exam to validate your QSR knowledge, Medical Devices Regulatory Framework etc.”

截至目前,超过 96+ 人们已经注册了这门课程,而且已经结束了 33+ 评论.

课程内容
Practice Tests

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9. Project Management for Medical Devices 经过 Josh Simon Udemy课程

Merging solid project management concepts with medical device development

截至目前,超过 90+ 人们已经注册了这门课程,而且已经结束了 29+ 评论.

课程内容
Introduction and Getting Started – Phase I
Project Management Process and Medical Device Development – Phase II
Project Management Knowledge Areas
Project Management Application and Example: Clinical Trial for a Medical Device

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10. European Medical Device Regulatory Basics 经过 Josh Simon Udemy课程

A beginner’s primer to medical device regulation in Europe.

截至目前,超过 62+ 人们已经注册了这门课程,而且已经结束了 33+ 评论.

课程内容
European Medical Device Regulatory Basics

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下面是一些关于学习的常见问题医疗设备开发

学习医疗设备开发需要多长时间?

“学习医疗设备开发需要多长时间”这个问题的答案是。 . .这取决于。每个人都有不同的需求,每个人都在不同的场景下工作,所以一个人的答案可能与另一个人的答案完全不同。

考虑这些问题:你想学习 医疗设备开发 是为了什么?你的出发点在哪里?您是初学者还是有使用 医疗设备开发 的经验?你能练习多少?每天1小时?每周40小时? 查看本课程关于 医疗设备开发.

医疗设备开发 学起来容易还是难?

不,学习 医疗设备开发 对大多数人来说并不难。检查这个 关于如何学习的课程 医疗设备开发 立刻!

如何快速学习医疗设备开发?

学习 医疗设备开发 最快的方法是先得到这个 医疗设备开发 课程, 然后尽可能练习你学到的任何东西。即使每天只有 15 分钟的练习。一致性是关键.

在哪里学习 医疗设备开发?

如果您想探索和学习 医疗设备开发,那么 Udemy 为您提供了学习 医疗设备开发 的最佳平台。查看此 关于如何学习的课程 医疗设备开发 立刻!