The Programming Buddy Club Logo
The Programming Buddy Club

ISO 13485: Medical Devices QMS Certification Masterclass | Free Udemy Course
Scroll Down to get the courseGet The Course

ISO 13485: Medical Devices QMS Certification Masterclass | Free Udemy Course

Free $84.99100% off
Price expires 1 year ago or 889 uses

Learn ISO 13485 from scratch for medical devices development, production, storage and distribution or installation | Free Udemy Course

(128 ratings)
12124 students
Created by:
Last updated 9/2022Course Language EnglishCourse Caption English [Auto]Course Length 09:02:05 to be exact 32525 seconds!Number of Lectures 49
This course includes:
  • 9 hours hours of on-demand video
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of completion

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 demonstrate 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 devicesWho this course is for:Quality Assurance SpecialistsQuality Assurance EngineersProject ManagersResearch and Development ProfessionalsVerification and Validation ProfessionalsProcess Development EngineersBusiness Owners looking to implement ISO 13458Operation ProfessionalsBusiness Students and GraduatesProfessionals working with in ISO 13485, QSR ISO 9001, 21 CFR 820Six Sigma and Quality Control Professionals

Course Content:

Sections are minimized for better readability, click the section title to view the course content

1 Lectures | 02:38
2 Lectures | 13:22
1 Lectures | 03:20
4 Lectures | 51:53
11 Lectures | 01:09:07
6 Lectures | 01:15:38
21 Lectures | 04:39:21
3 Lectures | 46:46
(128 course ratings)






If you like to get inspired by great web projects, you should check out Made with Javascript. If you have a project that you wish to share with the world, feel free to submit your project on Made with Javascript Club website.

Free Online Tools And Converters for your use

URL Encoder

Input a string of text or a URL and encode the entered string

Try it

URL Decoder

Input an encoded string of text or a URL and decode the entered string

Try it

Color Contrast Checker (WCAG)

Calculate the color contrast ration for your website (WCAG)

Try it

XML Formatter

Paste or upload an XML and have it formatted to a beautiful XML format

Try it

URL Slug Generator

Convert any title or sentence into a variety of slugs for your pages URL

Try it


Draw an e-signature or type a signature for your online signature

Try it

FAQ: Udemy Free course Most frequent questions and answers

Does Udemy offer Free Udemy coupons?

Yes, Udemy is the largest online education platform, with the broadest selection of video-on-demand courses and qualified instructors available to meet your needs. At we curate the latest udemy coupons, their expiry, and the number of uses left of these udemy coupons.

How to get free Udemy courses?

There are two ways to get free Udemy courses:

  1. Go to and search for your desired course category. Then select free from the filter options.
  2. You can also get paid courses for free if you have a coupon. You can head to, where you can get a daily udemy paid course for free.

How to get Udemy Certificates for free?

Udemy offers certification on completion of each course. In order to receive a certificate of completion from Udemy, you need to complete your course 100%. There is a simple hack, you can open a video and jump on the timeline to complete a lecture.

To download the certificate from Udemy, you need to head over to your account on a desktop browser. Udemy certificates can't be accessed on the mobile app.

Do Udemy courses expire?

No, once you enroll, you will have lifetime access to the course. You can complete the course on your schedule.

Why are the Udemy instructors giving away free Udemy Coupons?

Every instructor has worked for hours on each of their courses. As new courses get launched, the instructors have no way to get their course in front of an audience to get some feedback. So, instructors share free coupons for their courses to get feedback from the students. We work with these instructors to get their courses available to our buddies.

Is Udemy safe to use?

Yes, payments on Udemy are safe. It is no different than paying for other services on an application or website and inputting your payment information before receiving your goods. Just be sure to keep your account secure, do not share your udemy accounts.

Can Udemy courses get you a job?

Earning a skill is more valuable than earning a job these days. Skills are your most valuable asset. They can help you qualify for jobs you want and get promoted to more advanced positions within your organization. Unfortunately, it is difficult for many people to balance taking courses with work and family obligations. We have had many students, who have taken just Udemy courses, started a job as well as started freelancing with the skills they have learned.