ISO 13485 Foundation Certification Training
The ISO 13485 Foundation training equips participants with the fundamental knowledge needed to implement and manage a Medical Devices Quality Management System (MDQMS) according to ISO 13485 standards. This training delves into the core components of an MDQMS, covering areas such as policy development, performance measurement, internal audits, and continual improvement processes.
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About ISO 13485 Foundation
Our ISO 13485 Foundation Certification Training offers a comprehensive understanding of Medical Devices Quality Management Systems (MDQMS) and their significance in the healthcare industry. Participants will learn essential methodologies and approaches for implementing and managing an MDQMS, aligning with ISO 13485 requirements. Through interactive sessions and practical exercises, participants will grasp the essential concepts and gain insights into the correlation between ISO 13485 and other regulatory frameworks.
ISO 13485 Foundation Key Features
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Why should I get the ISO 13485 Foundation Certification Training?
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Brisbane
Live Online Training
A$ 2124 A$3186
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- 24x7 learner assistance and support
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A$ 4319 A$6478
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- We can deliver both In-Person or Live Online
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Download Course Agenda And Company Brochure
Course Agenda
Company Brochure
Overview of ISO 13485 Foundation Certification Training
Our ISO 13485 Foundation Certification Training is designed to provide participants with a comprehensive understanding of Medical Devices Quality Management Systems (MDQMS) according to ISO 13485 standards. This program covers essential aspects such as policy development, procedures, performance measurements, internal audits, and continual improvement processes. This training is designed with a mix of theoretical knowledge and practical applications to help you gain insights into aligning MDQMS practices with regulatory frameworks and industry standards.
With a focus on experiential learning, our training facilitates hands-on exercises and case studies, enabling participants to apply theoretical concepts to real-world scenarios.
Program Highlights
Expert Guidance:
Learn from seasoned professionals with practical experience in Medical Devices Quality Management, providing invaluable insights and guidance throughout the training.
Hands-On Learning:
Engage in interactive exercises, case studies, and discussions to apply theoretical knowledge to real-world scenarios, enhancing your understanding and skills in MDQMS implementation.
Tailored Approach:
Experience personalized learning designed to accommodate various learning styles and expertise levels, ensuring a thorough grasp of ISO 13485 requirements and best practices.
Industry-Recognized Certification:
Earn the esteemed "PECB Certificate Holder in ISO 13485 Foundation" credential upon successful completion of the certification exam, demonstrating your proficiency in Medical Devices Quality Management.
Learning Objectives
- Understand the fundamental principles and concepts of MDQMS
- Establish, maintain, and continually improve an MDQMS framework
- Apply techniques for effective implementation and management of an MDQMS
- Recognize the correlation between ISO 13485 and other frameworks in healthcare industry
- Record, report, monitor, and review the framework to ensure continual improvement.
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This training course is ideal for:
- Professionals in Medical Devices Quality Management
- Individuals responsible for implementing or managing MDQMS in healthcare organizations
- Quality assurance professionals in the medical device industry
- Consultants and advisors aiming to specialize in Medical Devices Quality Management
- Industry-Recognized Expertise:
Learn from certified professionals with practical experience in Medical Devices Quality Management, offering valuable insights and guidance throughout the training. - Interactive Learning:
Engage in practical exercises and discussions to apply theoretical knowledge to real-life scenarios, enhancing your understanding and skills in MDQMS implementation. - Flexible Learning Options:
Choose from in-person or online training formats to accommodate your schedule and preferences, ensuring a seamless learning experience.
Course Agenda
- Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
- Day 2: Medical Devices Quality Management System requirements and Certificate Exam
Examination
The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:
- Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Medical Devices Quality Management System (MDQMS)
Certification
Upon successfully completing the exam, you can apply for the "PECB Certificate Holder in ISO 13485 Foundation" credential, demonstrating your proficiency in Medical Devices Quality Management according to ISO 13485 standards.
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Participant Reviews
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Eric Williams 4
Feb 18th, 24
Project Manager at Yinlun TDI, LLC
Material is tough but the training and tools provided were good.
Craig Boggs 5
Apr 9th, 24
F-35 Senior Logistics/Sustainment Manager
This course fulfilled all the needs to prepare me for taking the PMP Exam. The professor extremely had the experience in teaching the course and felt he answered all of our questions.
Jing Li 5
Jan 23rd, 24
Sr. Oracle Application Business Analyst
It's really helpful training. I did learn a lot regarding the Lean Six Sigma. I believe I am able to pass the exam and get certification after the training.
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Terence Bourke 5
Oct 15th, 24
Senior Consultant, Info Technology
My trainer Dan Chauncey was extremely helpful with practical experiences that he conveyed regarding several of the questions that I had. The information is extensive. And the tools that have been provided are very detailed and understandable. Thorough training. Looking forward to more in the future.
Jonah Carroll 4
Oct 1st, 24
IT Support Tier 1
The trainer did well covering a wide range of topics in 4 days, although I would have liked some more real-life representations of what was being shown.Perhaps VMs, or examples of how viruses work in a real-to-life environment.Aside from that, I thought the course was very informative and helped build a framework for an understanding of Security+. We were also provided 12 hours of CompTIA labs that I think will be a HUGE help.
Shaun McElrath 5
Feb 17th, 24
Senior Manager, IT Business Enablement & Success
Understood the ITIL concepts very clearly. The trainer's faculty was so polite and ground to earth while explaining the concept and answering all the questions asked by the participants.
Yogi Sankepally 5
Apr 5th, 24
Independent IT Consultant
Class: "AWS Solution Architect Associate"
Small class size, with more emphasis on hands-on practice for each topic covered. The trainer Ameya Vaidya is knowledgeable and explains lucidly with real-life examples. Would definitely recommend.
Ravi Kumar 5
Mar 20th, 24
Change Implementation Analyst
The firm is very welcoming and the exam for the ITIL v4 itself went really well. the provide excellent learning materials and real-time examples in the videos to understand the concepts.
Regina Ogbone 5
Jul 11th, 24
Senior System Engineer
"I've never completed a course like this before (remotely) and I cannot express how great the instructor was and the overall content of the material. The way he taught was very clear in his method of teaching. The instructor was very knowledgeable and provided a wealth of information about the current version of CompTIA Security+. All my questions were answered and the class interaction was very good. I loved the fact that even though I was in a class with other people, the actual physical space was quiet and very conducive to learning! Thank you.
Safiqul Sarkar 4
Mar 18th, 24
Certified Microsoft Engineer
Concepts have been explain with real world examples. Key is to forget organizational practices when opting for ITIL and keep and open mind about the concepts and not mix it.
It was a great learning experience
No, there are no prerequisites for this training, making it accessible to individuals at various stages of their career in Medical Devices Quality Management.
This training enhances your expertise in MDQMS implementation and management, paving the way for career advancement and opportunities in the healthcare industry.
The training offers in-depth coverage of ISO 13485 standards, practical exercises and discussions, industry-recognized certification, and CPD certification credits to enhance professional credibility.
This training is suitable for individuals involved in Medical Devices Quality Management, professionals seeking to enhance their knowledge of MDQMS, and those interested in pursuing a career in this field.
The training spans across 2 days, covering essential concepts and practical applications of ISO 13485 standards and MDQMS implementation.
Participants can choose from in-person or online training formats based on their schedule and preferences, ensuring flexibility in learning.
Yes, participants have the opportunity to retake the exam within 12 months for free, providing a chance to reinforce their understanding and obtain certification.
Yes, the certification is globally recognized and valued by employers and organizations in the healthcare sector, demonstrating proficiency in MDQMS implementation and management.
Certification validity periods may vary depending on the certification body. Check with PECB’s Certification Maintenance Policy for information on certification renewal and maintenance requirements.
Frequently Asked Questions
Sprintzeal's training stands out due to its comprehensive curriculum, industry-recognized certifications, experienced instructors, and personalized learning options, ensuring a rewarding and effective training experience.
Sprintzeal offers flexible training formats, including in-person, online, and corporate training options, allowing participants to choose the format that best suits their schedule, learning style, and preferences.
Sprintzeal prioritizes quality and relevance by continuously updating its course content to align with industry standards and trends. Additionally, our instructors bring real-world experience to the classroom, enriching the learning experience.
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Yes, Sprintzeal offers post-training support, including access to additional resources, guidance from industry experts, and assistance with exam preparation, to facilitate continuous learning and career growth.
Yes, Sprintzeal's instructors are highly experienced professionals with extensive expertise in their respective fields, providing valuable insights, practical knowledge, and real-world examples during training sessions.
Yes, Sprintzeal offers customizable training solutions tailored to meet specific organizational needs, including content customization, onsite training options, and flexible scheduling, ensuring maximum impact and relevance.
Yes, Sprintzeal provides customized corporate training solutions tailored to meet the specific needs and objectives of organizations, ensuring maximum impact and ROI. Contact Us to customize your training needs and know more about group discounts.
Yes, Sprintzeal offers group discounts for corporate training programs, providing cost-effective solutions for organizations looking to upskill their teams. Contact Us for more information.
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