+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?
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Malvern PA
Live Online Training
$ 1475 $2212
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- 24x7 learner assistance and support
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$ 2950 $4425
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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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Liza Barrick 4
Nov 8th, 23
Project Development Officer
Overall, the course was highly in depth and interactive. The instructor had a great knowledge of the topic and explained the content in full. While the instructor was great, I did have a hard time understanding their accent and spent a decent amount of time trying to understand what was said rather than the content. Ultimately, I will have to re-listen to the recordings or teach myself the content I did not understand. I did have a few issues regarding the preparation of the program. It would be beneficial to the student to know exactly what the program will entail and what is expected of them such as: what technology is required, the level of participation, and the expected schedule of the program. The support team answered emails quickly, and sent out the recordings in good time. I believe this was a good experience to have and to prepare for the PMP test.
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Elaine Park 5
Oct 14th, 23
Senior Manager
The course content is comprehensive and invaluable! I gained key understandings that I wouldn't have gained studying on my own. The instructor is extremely knowledgeable in PMI and PMP, with expert experience in project management. They made hard concepts easy to access through simplified visuals and ample resources! I am confident that this course has prepared me well to succeed and pass the PMP test. I highly recommend this course.
Aijaz Shaikh 5
Feb 2nd, 24
Agile Project Manager experienced in Information Exchange, Digital Transformation, Cyber Security & Cloud Computing
Indeed, A Great Learning Experience !!! I am very thankful for choosing Sprintzeal as my training medium for PMP. All the team members from Sprintzeal spent a whole lot of time with me right from the start of my application until my application was accepted by PMI. I am personally thankful to David Johnson and Alex Wood for all their assistance along the way. The training part from Sprintzeal has the class of its own. It has been such a good learning experience. I am jazzed to admit that Tammy (the instructor) made the entire journey of understanding PMP terminology and concepts a great experience. She is crystal clear about all of the mathematical concepts associated with PMP. This is really helpful in understanding the project management concepts She got the whole training properly structured and easy to follow Sprintzeal course material to meet the course learning objectives. She got right to the point and helped me understand all the important bits in a timely manner.. Tammy is very patient to answer our question and covered all materials within 4 days. Moreover, she shares her past real PM experience with us and make this class more "practical" and assist us to combine work experience with theory. I learned a great deal of knowledge as well as exam-passing-tips in this intensive/productive class. With Sprintzeal came Tammy, both of them are awesome. Thank you both.
Shawn Roberts 5
Jun 4th, 24
Information Technology and Services Professional
I attended Sprintzeal's AWS Solution Architect course the past two weekends. The live remote classes were very interactive and involved lots of labs and hands-on work to enhance learning. The instructor, Raj, is EXTREMELY knowledgeable about AWS and is a great teacher. I will come back for future training needs. Thanks, Shawn
Lynne Colley 5
Jan 19th, 24
Clarity | Action = Corporate Real Estate and FM Consulting Coach
Best training ever. Muhammad Faisal was just the best tutor. By the end of 4 days training from zero start I was already achieving over 60 percent and then just had to follow up with the study plan and go ahead with the momentum. Nothing was too much trouble. Extremely supportive tutor who also coached me with the application process and heaps of tips for the exam. I know I am ready and I will come back and let you know when I pass in the next month. for sure.
David Todman 5
May 6th, 24
Senior Management Professional
The Six Sigma Training from Sprintzeal was very beneficial and provided in-depth information. In addition, my instructor Swati provided a wealth of information that clearly defined the Six Sigma methodology.
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.
Katrina Sarkisoff 5
May 14th, 23
Project Manager at Dealer-FX
Biswa was my teacher for the PMP prep and he was amazing I would defiantly recommenced for anyone interested n taking this course.
Russell Deatherage 5
Apr 12th, 24
Sr. Program Manager
PMP Boot camp by Syed M. Quadri on 21-25 Oct 2019. Excellent class. Mr. Quadri presented sound information and gave logic advice that was helpful to tie the information together for memory. Great point on the ITTO's that I and O are nouns and TT's are verbs or actions
Anetra Doherty 5
Feb 17th, 24
SFL Career Counselor at Inverness Technologies
Kevin Davis Phenomenal instructor that provided actual conceptual scenarios that focused on the overall PMP concept that I could relate to in the corporate culture. He was very patient and determined to ensure we stayed on track w/ the focus of understanding the fundamentals of PMP.
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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