IEC 62304 – Medical Devices Software Development & Processes

IEC 62304 – Medical Devices Software Development & Processes, available at $79.99, has an average rating of 4, with 22 lectures, 7 quizzes, based on 66 reviews, and has 3209 subscribers.

You will learn about Comprehend the IEC 62304 standard and what elements are there in software lifecycle processes Illustrate the FDA guidance along with IEC 62304 and compare the types of softwares and risks involved Compare the level of risks iterated in FDA guidance on medical device software and IEC 62304 and how do they coorelate Demonstrate your understanding about different types of medical device softwares This course is ideal for individuals who are The course is relevant for any professional working with software development, such as R&D engineers, quality assurance department and auditors of software development. or All those working in compliances for medical devices industry and want to extend their knowledge on software medical devices or Consultants working to support their clients on medical devices' software compliances or The course does not comprise of actual coding, rather compliance guidelines on software development. So don't expect that we will teach coding. It is particularly useful for The course is relevant for any professional working with software development, such as R&D engineers, quality assurance department and auditors of software development. or All those working in compliances for medical devices industry and want to extend their knowledge on software medical devices or Consultants working to support their clients on medical devices' software compliances or The course does not comprise of actual coding, rather compliance guidelines on software development. So don't expect that we will teach coding.

Enroll now: IEC 62304 – Medical Devices Software Development & Processes

Summary

Title: IEC 62304 – Medical Devices Software Development & Processes

Price: $79.99

Average Rating: 4

Number of Lectures: 22

Number of Quizzes: 7

Number of Published Lectures: 22

Number of Published Quizzes: 5

Number of Curriculum Items: 30

Number of Published Curriculum Objects: 28

Number of Practice Tests: 1

Original Price: $79.99

Quality Status: approved

Status: Live

What You Will Learn

Comprehend the IEC 62304 standard and what elements are there in software lifecycle processes
Illustrate the FDA guidance along with IEC 62304 and compare the types of softwares and risks involved
Compare the level of risks iterated in FDA guidance on medical device software and IEC 62304 and how do they coorelate
Demonstrate your understanding about different types of medical device softwares

Who Should Attend

The course is relevant for any professional working with software development, such as R&D engineers, quality assurance department and auditors of software development.
All those working in compliances for medical devices industry and want to extend their knowledge on software medical devices
Consultants working to support their clients on medical devices' software compliances
The course does not comprise of actual coding, rather compliance guidelines on software development. So don't expect that we will teach coding.

Target Audiences

The course is relevant for any professional working with software development, such as R&D engineers, quality assurance department and auditors of software development.
All those working in compliances for medical devices industry and want to extend their knowledge on software medical devices
Consultants working to support their clients on medical devices' software compliances
The course does not comprise of actual coding, rather compliance guidelines on software development. So don't expect that we will teach coding.

IEC 62304 standard explains the life cycle requirements for medical device software. The different processes, interrelated activities, and measures are described in this standard which develops an international protocol for standard processes related to medical device software life cycle. As the medical device itself is critical product therefore the software associated with it should also be dealt in a serious controlled manner.

This course on IEC 62304 is the first interactive course on medical devices software development. It will empower you to understand how to create and maintain safe software for medical devices throughout their life cycles. You will gain a robust understanding of important terminologies to allow you to comprehensively participate in discussions about software safety classifications and software risk management. Along with this, you should also assimilate how IEC 62304 interacts with other standards such as ISO 14971, ISO 13485, IEC 60601 series.

You will have unlimited access to the course and its educational materials. The great value within our online courses is that you can pause, re-watch and start again watching online lectures where you actually stopped. You can do this as many times as you like without any limitation whatsoever! This offers you with the comfort to learn what, how, where and when you want.

No need to pay thousand dollars for one day awareness course on the design and development of medical devices software. This course will suffice your requirement.

You will learn the about this new standard IEC 62304 requirements on software lifecycle development.

You will be taught following when you take this course (Course Objectives):

Basic information about the IEC 62304
Process for Software Development
Safety Classification
Documentation
Risk Management Process
Configuration Management
Problem Resolution
FDA, IMDRF Classification for SAMDs

COPYRIGHT NOTICE: Please note that this IEC 62304 standard is IEC copyright protected. A standard copy will NOT be issued with this course. However we offer all our presentation materials in PDFs to be downloaded. You can use the presentation material for your own learning without sharing it to someone else without permission.

Practice Exam:The course also comes with a practice exam to let you analyze yourself about the software lifecycle development.

Certification:A certificate is also available with this course. Once you complete all lectures and successfully pass the exam, you can have your certificate of successful completion of this course. Auditors can also inquire for your training on the IEC 62304. With this course, obviously you will have a professional course certificate (from Udemy) to show if you are inquired about this during. Therefore you can confidently answer the auditor whether you know IEC 62304 or not.

Certificate Issuance Alert from Exoexcellence:Many students have complained that they do not want the new Udemy Certificate (template issued last year). Rather, they wanted the older one. We have communicated their concern to Udemy’s management. But please note that is their standard and they are not going to change that for now. So in order to satisfy the need of our students, we have a designed certificate (which is being issued from Exoexcellence Training Resources) which seems satisfactory to our students; raising the concerns. Therefore, now we have a system within the course where you can request a certificate from us after completing the course.

One Month Money Back Guarantee:Don’t forget, this Course have comes with One Month 100% Money Back Guarantee. This means you have unconditionally no risk when registering to this Course.

Ask Questions & Report Complaints:Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course.

Take this course: Follow the “Take This Course” Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow it to register and pay for the course.

Course Curriculum

Chapter 1: Introduction to Medical Device Software & International Standards Governing it!

Lecture 1: Introduction to the Course, Sections & Instructor

Lecture 2: Medical Devices Software Classification with Examples

Lecture 3: International Standards relevant to IEC 62304 & Medical Devices Software

Lecture 4: Interaction of Standards for Software Development

Chapter 2: Application of IEC 62304 Content – A Brief Discussion

Lecture 1: Introduction to IEC 62304

Lecture 2: Brief Discussion on IEC 62304

Lecture 3: IEC 62304 Clause 1: Scope & Purpose

Lecture 4: Terms & Definitions

Lecture 5: Terms & Definitions Part 1

Lecture 6: Terms & Definitions Part 2

Lecture 7: Terms & Definitions Part 3

Lecture 8: Terms & Definitions Part 4

Lecture 9: Terms & Definitions Part 5

Lecture 10: Terms & Definitions Part 6

Chapter 3: Overview of Auditable Clauses of IEC 62304

Lecture 1: A Brief Overview of Auditable Clauses in IEC 62304

Lecture 2: A Detailed Overview of Requirements in IEC 62304

Chapter 4: FDA Guidelines on SAMDs & Case Study Comparison on Softwares

Lecture 1: Introduction to FDA and IMDRF Guidance Documents

Lecture 2: Case Study: Comparison on Software Medical Device and SAMD

Lecture 3: Risk Matrix for SaMDs

Lecture 4: Risk Categorization and its Examples

Lecture 5: Final Notes about Risk Structure of SaMDs

Lecture 6: Certificate Application Form

Instructors

Waqas Imam
Industrial Engineer | IRCA Auditor | Medical Devices Expert
Exoexcellence Training Resources
Management System, Process Excellence, Lean & Six Sigma

Rating Distribution

1 stars: 8 votes
2 stars: 5 votes
3 stars: 16 votes
4 stars: 19 votes
5 stars: 18 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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