ISO 13485 Medical Devices
Quality Management System
Trainings
ISO 13485 Medical Devices Quality Management System Trainings
As an international standard, ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal. However, ISO 13485 can also be operated by other parties such as certification bodies which can assist in the certification processes. ISO 13485 serves as a tool for organizations to develop and retain their processes efficiently. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers.Â
Being an ISO 13485 certified professional imposes your determination to offer qualitative products and services to your company and/or clients. Attaining the necessary knowledge and skills to operate an ISO 13485 framework demonstrates your commitment to helping your company ensure continuous improvement and better work processes. It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction. Similarly, it can introduce you to new opportunities, such as working for large companies that offer quality products and services. These companies will value your knowledge and expertise on this standard, while enabling you to maximize your earning potential.
By the end of this training course, the participant will be able to:
- Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand the approaches, methods and techniques used for the implementation and management of a MDQMS
- Managers or consultants responsible for the effective management of risk in an organization
- Individuals seeking to gain knowledge about the risk management principles, framework, and process
- Individuals responsible for the creation and protection of value in their organizations
- Individuals interested in pursuing a career in risk management
ISO 31000 Risk Manager
The ISO 31000 Risk Manager training course helps participants acquire the knowledge necessary and ability to integrate the risk management guidelines of ISO 31000 in an organization. It provides information with regard to the risk management principles and their application, as well as the core elements of the risk management framework and steps for a risk management process. In addition, it provides the basic approaches, methods, and practices for assessing risk in a wide range of situations.
By the end of this training course, the participants will be able to:
- Demonstrate understanding of risk management principles, as formulated in ISO 31000
- Establish, maintain, and continually improve a risk management framework, in accordance with ISO 31000 guidelines
- Apply the risk management process, in accordance with ISO 31000 guidelines
- Managers or consultants responsible for the effective management of risk in an organization
- Individuals seeking to gain knowledge about the risk management principles, framework, and process
- Individuals responsible for the creation and protection of value in their organizations
- Individuals interested in pursuing a career in risk management
Purchase Self-Study Course
Purchase E-Learning Course
Sign-Up for Instructor Led Training
Download the Brochure
The Self-Paced Study Experience
One of the major advantages of our self-study training course delivery format is that you can take control of your own learning and direct your own studying. This format is feasible for participants who have a considerable knowledge on the subject and do not require assisted lecturing.Â
Participants will have access to the training course material digitally via the KATE app. After completing the self-study training course, you can enter the exam from anywhere in the world through the PECB Exams app. Finally, those who successfully pass the exam will be invited to apply for certification.
The E-Learning Experience
Our ISO 31000 Risk Management eLearning training course is delivered on the KATE app. It becomes available after you log in using your PECB account.Â
In addition to having the training course content in the video format, you can also access the regular training course materials format, structured in training course days, with the additional files available in an editable format (depending on the training course, the case study, exercises, and exercises correction key files will also be available).
Quizzes are part of the training course to interactivity between attendants and the training material.
- Take the training course
- Access the materials on KATE
- Enter the exam at your most convenient date, time, and location via PECB Exams
Additional Details
- Certification and exam fees are included in the training session price
- You will be provided with the training course material containing over 300 pages of explanatory information, examples, best practices, exercises, and quizzes.
- An Attestation of Course Completion worth 21 CPD (Continuing Professional Development) credits will be issued to all of you who have attended the training course.
- In case you fail the exam, you can retake it within 12 months following the initial attempt for free.
Upcoming ISO 31000 Risk Manager Classes
For more info about this course, download the PDF using this form.
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