+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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Carson City NV
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$ 1475 $2212
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$ 2950 $4425
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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.
People also searched for:
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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Prakash Makapur 5
Mar 29th, 24
Solution Architect | Customer Project Manager
Syed M. Quadri is an outstanding instructor, very passionate about project management. Really goes the extra mile. Thanks, Lenord as well.
Ralph Scheunemann 4
Mar 23rd, 24
Sr. Infrastructure Planning Engineer at City of Barrie
The training was direct to the point. The resource material is excellent.
Krishna Sripada 5
Jul 10th, 24
Tech Lead
I have taken the AWS Solution Architect Associate Certification training course. Toshal Kahawale was the trainer. Toshal had covered all the important topics required for a Solution Architect in a detailed manner. He had provided real-world application examples while explaining the topics. That was really helpful. Toshal has plenty of experience in designing & architecting cloud applications
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.
Mohammed Hattab 5
Jun 4th, 24
Field Computer Technician
My experience with sprintzeal was great everyone was helpful and they did a great job accommodating my tight schedule. I took the CompTIA A+ course with Risk Ascher as my instructor.
Bandar Al Jasser 4
Mar 3rd, 24
Continuous Improvement Manager
The facilitator, Ms. Noor Zohara was extremely helpful and made our life easy in registration any queries or information about the course. She is very organized, friendly and supportive of the applicants. The speaker Mr. Mohammad Al Rumaih, was knowledgeable, very nice, informative, skillful, highly professional and really made it real with real-life examples. We are feeling that we are confident enough to take the exams and start our own project management. There are some areas for improvement in the venue it’s relatively small, hot water is not available all the time for making hot beverages. Otherwise, everything was fine and thanks again. I will definitely repeat my experience with sprintzeal again and again.
Christi Sifri 4
Jan 19th, 24
CHIEF NURSE EXECUTIVE | GLOBAL CLINICAL PROGRAM DIR ORG & STAFF LEADERSHIP | CLINICAL RESEARCH| REGULATORY COMPLIANCE
Dani is a very knowledgeable project manager, with real-life experiences and stories. He was able to take the slides provided by Sprintzeal and know if they were from PMBOK 5 or PMBOK 6, what was enhanced, what was deleted, and apply an example that made sense to the topic. Dani's biggest challenge was the GoToMeeting process and landing back on the slide deck after providing additional information to teach a particular point. It is challenging to teach people on different coasts, but he was able to and respect the time difference.
Review of Sprintzeal: Alex reached out to me and walked me through the entire registration process, answering all of my questions and there were many. I was supposed to have a live class, but because I ended up being the only person that did not cancel they transferred me into an on-line class and have offered an additional class to make up for that. I received my PMBOX 6 book ahead of class and found everything very straight forward. I hope that the three mock tests and assistance in completing my application are as clear and efficient as the rest of this has been.
I have 4 stars for the slide reading and technical challenges to date.
Thank you - Christi
David Carnell 5
Jan 18th, 24
Healthcare Project Manager
I was very pleased with my PMP trainer and the content and materials. The slides were very well done and logical so you could learn the subject matter looking at the slides and listening to the trainer. The trainer was very patient and thorough in making sure that I understood the subject matter and made sure any questions i had or uncertainty was addressed. I am very pleased with my PMP training experience.
Yasser Zubaidi 4
Mar 11th, 24
INTERNATIONAL BUSINESS DEVELOPMENT STRATEGIST & ARCHITECT
Mohmmad Erfan gave the course in a very professional way he simplified the subject and made it easy to grasp I definitely recommend Sprintzeal for PMP exam prepration.
T Bourke 5
Sep 15th, 24
Director of Operations
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 umderstandable. Thorough training. Looking forward to more in the future.
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.
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