+1 315 666 4295ISO 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?
Mode Of Training
Chambersburg PA
Live Online Training
$ 1475 $2212
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- 24x7 learner assistance and support
Classroom Training
$ 2950 $4425
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- Pay after the training completion
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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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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.
Ahmed Shahein 5
Aug 16th, 24
Assistant Superintendent at MAPP, LLC
Enjoyed, great atmosphere although it online. Trainer is an expert in sharing and delivering knowledge. Sprintzeal management is great and very assisting and helping.
Bernadette Vida 5
Mar 12th, 24
IT Program Manager, Business Owner
Dana is an excellent instructor. He had a lot of test taking and industry experience. I noticed that the power point and test material references the 5th edition. For example, the reference to Quality Audit which is in the 6th Edition called Quality Assurance. Dana was able to point these out and reduce confusion.
Mark Ridgely 4
Aug 9th, 24
Project Manager
Instructor very knowledgeable of the PMI content and provided solid instruction as such as well as practical experience in exam preparation and test taking strategy.
Online version of class was better than anticipated, but think I still would have preferred in person classroom setting.
Chris Engel 5
Mar 16th, 24
Director of Client Delivery
Sprintzeal and Oscar "Dani" Chaparro were great! My training and experience with Sprintzeal and my trainer Dani, for my PMP certification, was excellent. I am preparing and getting ready to take the PMP certification exam and feel this certification preparation training has been instrumental and critical to passing the exam. Thank you Sprintzeal and Dani! Source - Trustpilot
Neetha Kotagiri 5
Feb 3rd, 24
System Administrator/ at AGCO Corporation
PMP Training provided by Sprintzeal The training is amazing. Trainer Tammy is so good she is very understanding, Patient and very good teacher. She made the most difficult topics very easy. I loved training with her. Alex Wood from Sprintzeal who help me with the process of the enrollment was very good. Answered each and every concern of mine and was very helpful.
Archana Kalwani Sajnani 4
Oct 1st, 23
Business Operations Manager
I have completed my six sigma green belt training. The admin staff, support team and the trainer were very helpful and flexible. The trainer was very good and helped understand the concepts well. Thank you for all the support.
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Sean Allen 5
Feb 19th, 24
Health Services Comptroller at US Army
Carmen was exceptional, knowledgeable and had a wealth of practical experience. She provided superb facilitation of PMP instructions that will aid me on the upcoming PMP test. Carmen's transparency and presentation is an asset and a must have in the classroom setting.
Rosalind Andry 4
Feb 25th, 24
CNS Sales Specialist | ADHD Specialist
Lots a great data. Wish more pictures, graphics, and real life examples just to make it more interesting. Also, please provide an acronym and definitions list.
Rita Wiley 5
Mar 23rd, 24
Transitioning Officer in pursuit of PMP and MBA
Tim was beyond amazing. Not only did he know his craft, but he was also able to explain it to a level someone with the lowest level of knowledge could understand, without insulting the intelligence. I came in with barely any formal knowledge of the PM world and ended leaving with way more competency. Tim mixed personal experience and PMI terms/processes/knowledge areas to increase my understanding (it worked). Loved this class, loved the teacher. I will definitely recommend this class and more specifically, the teacher to other coworkers, friends and family. Thank you!
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.
Yes, Sprintzeal provides training programs catering to all skill levels, from beginners to experienced professionals, ensuring comprehensive learning experiences for all participants. Explore our courses.
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.
Sprintzeal's refund policy allows for cancellations and refunds within a specified timeframe, ensuring customer satisfaction and peace of mind. Please refer to our terms and conditions or Contact Us for details.
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