ISO 13485:2016 - Quality Management Systems for Medical Devices
4.7 /5- Offered byAlison
ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Overview
ISO 13485:2016 - Quality Management Systems for Medical Devices
at Alison
Learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.
Duration | 3 hours |
Mode of learning | Online |
Difficulty level | Beginner |
Official Website | Go to Website  |
Credential | Certificate |
ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Highlights
ISO 13485:2016 - Quality Management Systems for Medical Devices
at Alison
- Earn a digital Certificate and become an Allison Graduate on scoring above 80% in assessments
- Update yourself with latest ISO standard
- Trainer & Facilitator-S.M. Waqas Imam
ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Course details
ISO 13485:2016 - Quality Management Systems for Medical Devices
at Alison
Skills you will learn
What are the course deliverables?
- Compare the revision of ISO 13485:2003 to ISO 13485:2016
- ist the main clauses of the ISO 13485:2016 standard along with the requirements
- Define important terminologies about medical devices as per ISO 13485:2016
- Explain the purpose of other international and regulatory standards like ISO 14971 and FDA 21 CFR Part 820
- Compare ISO 13485 with FDA 21 CFR Part 820
- Describe how to manage the requirements about medical device files
- Illustrate how to assimilate work environment and contamination control requirements
- Describe how to manage the requirements about design and development
More about this course
- This free online ISO 13485:2016 course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies and definitions related to stakeholders, product, QMS, Risk and Sterilization, and more.
ISO 13485:2016 - Quality Management Systems for Medical Devices at Alison Curriculum
ISO 13485:2016 - Quality Management Systems for Medical Devices
at Alison
Introduction to ISO 13485:2016 (Medical Devices QMS)
Introduction to ISO 13485:2016 (Medical Devices QMS) - Learning Outcomes
Quality Management System of Medical Devices Suppliers and Manufacturers
ISO 13485:2016 Important Terminologies
Publication of ISO 13485:2016 and Context of Publication
>Introduction to ISO 13485:2016 (Medical Devices QMS) - Lesson Summary
Operations of Quality Management System (QMS)
Operations of Quality Management System - Learning Outcomes
Quality Management System Requirements
Management Responsibility and Resource Management
Product Realization ? Planning to Design and Development
Product Realization ? Purchasing and Production
Operations of Quality Management System - Lesson Summary
Measurement, Analysis and Improvement
Measurement, Analysis and Improvement - Learning Outcomes
Monitoring and Measurement
Control of Non-Conforming Product
Analysis and Improvement
Measurement, Analysis and Improvement - Lesson Summary
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S
Susant Kumar Nayak
ISO 13485:2016 - Quality Management Systems for Medical Devices
Offered by Alison
4
Learning Experience: Course about plan do check act
Faculty: Faculty was good.
It's good. Like the course.
Reviewed on 4 Mar 2023Read More
M
Mr KIRAN LANDE
ISO 13485:2016 - Quality Management Systems for Medical Devices
Offered by Alison
5
Learning Experience: It was very good session for us it was very useful to ramp up my QMS knowledge and it's important
Faculty: Faculty is very good speaking and knowledge
Yes they give a one question paper as lesson was we leaned
Reviewed on 3 Feb 2023Read More
P
Pooja Mishra R
ISO 13485:2016 - Quality Management Systems for Medical Devices
Offered by Alison
5
Learning Experience: I have taken a training of iso 13485 -2016 from zenith quality assessors amd it was a great experience.
Faculty: Feculty was a experienced auditor and he has lots of knowledge
The course was 2 day online class
Course Support: I am quality assurance officer in medical device manufacturing company and it is very huge benifit for attending and knowing about iso 13485 because all your works are related to iso and standards
Reviewed on 21 Jan 2023Read More
L
Likitha L
ISO 13485:2016 - Quality Management Systems for Medical Devices
Offered by Alison
5
Learning Experience: Such a good experience
Faculty: Quality of teaching was amazing, such a good experience with the session.Thank you for the experience
Reviewed on 21 Jan 2023Read More
A
Ashwani Kumar
ISO 13485:2016 - Quality Management Systems for Medical Devices
Offered by Alison
5
Learning Experience: Awesome course
Faculty: Great
Good and informative
Reviewed on 31 Dec 2022Read More
View All 11 Reviews
ISO 13485:2016 - Quality Management Systems for Medical Devices
at Alison
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