10 Best Iso 13485 Courses and Certifications Online

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Close up iPhone showing Udemy application and laptop with notebookThere are countless online courses and classes that will help you enhance your Iso 13485 abilities and earn your Iso 13485 certificate.

In this post, our experts have actually put together a curated list of the 10 Best of the Best Iso 13485 courses, tutorials, training programs, classes and certifications that are available online right now.

We have actually included only those courses that satisfy our top quality standards. We have actually put a lot of effort and time into gathering these all for you. These courses are suitable for all levels, beginners, intermediate learners, and experts.

Here’s a look at these courses and what they have to offer for you!

10 Best Iso 13485 Courses and Certifications Online

1. ISO 13485:2016 – Awareness on Medical Devices Development by Waqas Imam Udemy Course Our Best Pick

Basic understanding on ISO 13485:2016 International Standard on Design and Development Process in Medical Devices

As of right now, more than 7329+ people have enrolled in this course and there are over 596+ reviews.

Course Content
Introduction to ISO 13485:2016 & Medical Devices Design and Development Process
ISO 13485:2016 Specific Auditable Requirements on Design and Development

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2. Medical Device Process Validation. ISO 13485. IQ OQ PQ. by Martin Conneely Udemy Course

“Validate a process to gain approval to sell medical devices in the EU, U.S. & Internationally. Compliance to ISO 13485.”

As of right now, more than 1582+ people have enrolled in this course and there are over 428+ reviews.

Course Content
Introduction
Process Validation
Section 3 Process Capability
Section 4: Risk Management
Section 5 Process Validation Documentation
Section 6 History of regulation
Section 7 Bonus Lecture

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3. Medical Devices Quality Management System – ISO 13485:2016 by Stendard Academy Udemy Course

Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS.

As of right now, more than 955+ people have enrolled in this course and there are over 420+ reviews.

Course Content
Introduction – Getting started on the ISO 13485:2016
Clauses-by-clause guidance for ISO 13485:2016
Preparation of documentation
Implementation
Verification of your implementation

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4. ISO 13485:2016 – Design and Development of Medical Devices by “Waqas Imam, Exoexcellence Training Resources” Udemy Course

Design and Development of Medical Devices in the perspective of ISO 13485:2016 and Medical Devices Industry

As of right now, more than 947+ people have enrolled in this course and there are over 371+ reviews.

Course Content
“Introduction to ISO 13485:2016 & Medical Devices Design and Development Process
Design and Development Planning and Procedure
Design and Development Inputs and Outputs
Design and Development Reviews, Verification and Validation
Design and Development Transfer, Changes and Files
ISO 13485:2016 Specific Auditable Requirements on Design and Development
Practice Exam”

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5. EU Medical Device Regulatory Affairs explained Simply by Martin Conneely Udemy Course

How to get approval to sell Medical Devices within the European Union. Understand regulatory affairs & ISO 13485 2016

As of right now, more than 916+ people have enrolled in this course and there are over 320+ reviews.

Course Content
Introduction

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6. ISO 13485 – IQOQPQ – Process Validation for Medical Devices by Phaniendra Somraj Udemy Course

“Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) || Medical Devices”

As of right now, more than 673+ people have enrolled in this course and there are over 205+ reviews.

Course Content
Introduction
PREPARATION FOR PROCESS VALIDATION
IQ OQ PQ – PROCESS VALIDATION

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7. Internal audit on Medical Device QMS – ISO 13485:2016 by Stendard Academy Udemy Course

Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS

As of right now, more than 564+ people have enrolled in this course and there are over 254+ reviews.

Course Content
General concepts and principles of auditing
Establishing and preparing for the audit
Performing the audit (How to conduct a mock audit based on compiled checklist?)
Reporting the audit results
Post-audit activities and CAPA planning

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8. ISO 13485:2016 QMS – Lead Auditor Preparation Exam by “Exoexcellence Training Resources, Waqas Imam” Udemy Course

“ISO 13485 Practice Exam | Validate QMS Standard knowledge, Medical Devices Regulatory Framework | Audit Case Studies”

As of right now, more than 175+ people have enrolled in this course and there are over 41+ reviews.

Course Content
Practice Tests

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9. ISO 13485:2016 Medical Devices QMS Self-Assessment Test by 3L Resources Udemy Course

Comprehensive ISO 13485 self-assessment tests to gauge your level of understanding

As of right now, more than 105+ people have enrolled in this course and there are over 1+ reviews.

Course Content
Practice Tests

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10. MDQMS ISO 13485 by Wael Al sayed ahmed Hassan Neama Udemy Course

ISO 13485:2016

As of right now, more than 4+ people have enrolled in this course and there are over 0+ reviews.

Course Content
MDQMS ISO 13485

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