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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North Charleston SC
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$ 1996 $2994
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$ 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.
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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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Judy Denny 5
Dec 10th, 24
Manager of Facilities Services Operations at University of Hartford Facilities Department
The support staff from Sprintzeal,Steve Jones, were very supportive in making this decision to take the PMP certification course. The course was very affordable and I was given an additional incentive to take another course which would supplement my knowledge which was the Agile course.
I was thinking about studying on my own for the exam but decided to sign up for the course on Sprintzeal to ensure that the material that I needed to study was accurate and efficient. I didn't want to waste anytime on taking the exam multiple times to pass due to being ill-prepared. The instructor Biswa, was great in covering what to know for the exam and I feel that the material he provided will prepare me to pass the exam my first time with confidence. Thank you for this opportunity and I look forward to taking more certification courses through Sprintzeal.
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Sep 16th, 24
Team Lead at Schroders
The training offered by Sprintzeal is one of the most comprehensive and complete training. Right from beginning of my interaction with support team especially Foram for registration of course to actual training by an expert trainer to conducting exam online it was a pleasant experience. The trainer Mr Faizal is very knowledgeable and made the topic very easy to understand by giving realistic example with support from a detailed training material offered. Would highly recommend the valuable training sessions at reasonable pricing point. Keep up the good job.
Michael Hanson 4
Jun 26th, 24
US Army EOD Team Member
The instructor is experienced, this is obvious. To help drive home the point in instructing, they should use personal experience more often. Less reading of the data on the slides. The class was helpful.
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Jun 14th, 24
System Engineer
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 and provided a wealth of information about the CompTIA Network+. All my questions were answered and the class interaction was very good.
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Feb 14th, 25
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.
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Jun 26th, 24
IT Project Manager
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May 19th, 24
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Tarun was honestly the best trainer/coach that I've had in 20 years in the IT profession. He covered the EA/TOGAF material and had real life examples to make everything completely understandable. He listened to my professional concerns and questions and offered advice/suggestions from his years of experience. He genuinely cared about my understanding and was truly a mentor in so many areas related to EA and beyond enterprise architecture. His willingness to share his experiences and his passion to help others grow was very evident and so appreciated. Thank you so very much for the awesome week!
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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
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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.
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