+1 315 666 4287ISO 13485 Lead Implementer Certification Training
The ISO 13485 Lead Implementer training equips participants with the expertise to support organizations in establishing, implementing, managing, and maintaining a Medical Devices Quality Management System (MDQMS) according to ISO 13485 standards. This intensive program covers key activities and best practices essential for implementing and improving MDQMS effectively.
Training Options
About ISO 13485 Lead Implementer
Our ISO 13485 Lead Implementer Training offers participants a deep dive into MDQMS concepts and principles aligned with ISO 13485 standards. Through interactive sessions, practical exercises, and case studies, participants will gain the knowledge and skills required to effectively plan, implement, manage, and continually improve a MDQMS. Upon completion, participants will be equipped to advise organizations on implementing best practices in Medical Devices Quality Management.
ISO 13485 Lead Implementer Key Features
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Why should I get the ISO 13485 Lead Implementer Certification Training?
Mode Of Training
Aberdeen MD
Live Online Training
$ 1996 $2994
- Live Online Training by Industry Experts
- Best Price Guaranteed in the Training Industry
- Flexible Learning Modes for Efficiency
- 24x7 learner assistance and support
Classroom Training
$ 3992 $5988
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- Access to Course and Study Materials
- We Guarantee Best Price In Training Industry
- Flexible learning modes for efficiency
Corporate Training
- We can customise the training
- Flexible pricing options
- 24x7 learner assistance and support
- We can deliver both In-Person or Live Online
- Pay after the training completion
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Course Agenda
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ISO 13485 Lead Implementer Training - Overview
Our comprehensive ISO 13485 Lead Implementer Certification training program spans five days, providing participants with in-depth insights into establishing and managing a Medical Devices Quality Management System (MDQMS) in accordance with ISO 13485 standards. Covering essential topics such as MDQMS initiation, planning, implementation, monitoring, and improvement, this course equips participants with the knowledge and skills needed to excel in MDQMS implementation. Key topics include implementation methodologies, performance evaluation, continual improvement, and effective management of MDQMS.
Program Highlights
Expert Guidance:
Learn from certified professionals with practical experience in Medical Devices Quality Management, offering valuable insights and guidance.
Hands-On Learning:
Engage in practical exercises, case studies, and discussions to apply theoretical knowledge to real-world MDQMS scenarios.
Tailored Approach:
Experience personalized learning tailored to your expertise level, ensuring a comprehensive understanding of ISO 13485 implementation.
Industry-Recognized Certification:
Earn the globally recognized "PECB Certified ISO 13485 Lead Implementer" credential, enhancing professional credibility in Medical Devices Quality Management.
Learning Objectives
- Explain ISO 13485 concepts and principles on Medical Devices Quality Management.
- Establish, maintain, and continually improve a MDQMS.
- Apply ISO 13485 requirements in the specific context of an organization.
- Plan and implement effective MDQMS communication and consultation activities.
- Record, report, monitor, and review the MDQMS process and framework to ensure compliance and performance improvement.
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This comprehensive training course is suitable for:
- Managers or consultants involved in Medical Devices Quality Management.
- Members of MDQMS teams, IT professionals, and privacy officers.
- Individuals responsible for maintaining compliance with ISO 13485 requirements.
- Project managers, consultants, or expert advisers seeking to enhance skills in Medical Devices Quality Management.
- Industry-Recognized Expertise:
Learn from certified professionals with practical experience in implementing and managing Medical Devices Quality Management Systems. - Interactive Learning:
Engage in practical exercises and discussions to apply theoretical knowledge to real-life MDQMS scenarios. - Flexible Learning Options:
Choose from in-person or online training formats to suit your schedule and preferences, ensuring convenience and accessibility. - Post-Training Support:
Access resources and guidance to support ongoing learning and career advancement in Medical Devices Quality Management.
Course Agenda
- Day 1: Introduction to ISO 13485 and initiation of a MDQMS.
- Day 2: Planning the implementation of a MDQMS.
- Day 3: Implementing a MDQMS.
- Day 4: MDQMS monitoring, measurement, continuous improvement, and preparation for a certification audit.
- Day 5: Certification Exam.
Examination
The "PECB Certified ISO 13485 Lead Implementer" exam covers the following competency domains:
- Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Planning a MDQMS implementation based on ISO 13485
- Implementing a MDQMS based on ISO 13485
- Performance evaluation, monitoring, and measurement of a MDQMS based on ISO 13485
- Continual improvement of a MDQMS based on ISO 13485
- Preparing for a MDQMS certification audit
Certification
Upon passing the exam, you can apply for the "PECB Certified ISO 13485 Lead Implementer" credential, depending on your level of experience and fulfillment of relevant educational and professional requirements.
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Participant Reviews
Your career is our goal. We care for your professional empowerment. Don’t take it from us. Find out what our participants say about our service!
Robert Porto 5
Jun 26th, 24
Software Engineer
I have had a great experience with my AWS training with Sprintzeal. Originally the trainer I had my first training batch with, was a bit difficult for me to understand. She was honestly very knowledgeable but I couldn't grasp the concepts with her style. I reached out to Jason Caldwell/Leonard Paul about my early learning experience. I was incredibly pleased that I was moved to another trainers training batch. My new trainer (Paul Oyola) was easy for me to understand at a pace that was better fit for me. Paul was not only friendly from day 1 but remained that way throughout all of the classes. He was incredibly patient, knowledgeable, and efficient. If Paul didn't have an answer to a question one of the students asked, Paul would search for an answer and provide us with more information. I haven't taken the AWS exam yet, but I am confident I will pass and look forward to letting Paul know. I am so happy that I chose Sprintzeal for my AWS training. I am also pleased with the patience and customer service I received from the time Leonard Paul reached out to me to the time Jason Caldwell and Alex Wood assisted me as needed. Great experience all the way around!
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David Bennett-Pencil 4
Jun 4th, 24
Highly certified Microsoft Engineer with a Masters degree in Engineering
Security Plus training course. Very good experience overall.
Michael Hanson 4
Mar 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.
Tony, USA 5
Oct 25th, 24
Network Eng.
Highly Recommend CISSP Bootcamp With Tom
I have no complaints. The training was well paced, the materials seem to be spot on, and the trainer, Mr. Tom Scott, was an excellent trainer. I think I'm ready for the exam. Let's go!
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.
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!
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.
Cale Hansen 5
Feb 17th, 24
Transitioning Officer at US Army; Project Management; Military Aviation
Carmen did a fantastic job instructing our Class. From providing in depth analysis on course material to drawing from outside sources and personal experiences to fully flesh out the subject matter she placed a high level of importance on our understanding. Hoping all her hard work pays off on our success on the exam. I would unconditionally recommend her as an instructor and project manager!
Mitul Prafulbhai Bharwad 5
May 6th, 24
Business Development Expert
The training material was well organized and clearly explained by trainer. It was a nice experience and all the queries were well taken and explained to clear the doubts.
Lon Chin 5
Mar 18th, 24
Ass't Director - IT Security at US GAO
CISA Review - Good class and instructor. Would recommend.
If you're involved in Medical Devices Quality Management or seeking to enhance your skills in MDQMS implementation, ISO 13485 Lead Implementer Certification Training is the ideal choice to advance your career and expertise.
This training course is suitable for managers, consultants, project managers, IT professionals, and individuals responsible for maintaining compliance with ISO 13485 requirements.
Key features include comprehensive ISO 13485 coverage, practical exercises, industry-recognized certification, and CPD certification credits.
While there are no strict prerequisites, a fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles is recommended for participants to fully benefit from the training.
Yes, Sprintzeal offers flexible learning options, including in-person and online training formats, to accommodate participants' schedules and preferences.
The course agenda includes five days of training covering topics such as ISO 13485 introduction, MDQMS implementation planning, MDQMS implementation, MDQMS monitoring, and the certification exam.
The certification exam covers competency domains such as fundamental principles of MDQMS, MDQMS implementation planning, MDQMS implementation, performance evaluation, and preparation for a certification audit.
Upon passing the exam, you can apply for the "PECB Certified ISO 13485 Lead Implementer" credential through Sprintzeal, depending on your level of experience and fulfillment of relevant requirements.
Yes, in case of exam failure, you can retake the exam within 12 months for free.
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.
Yes, participants will have access to training materials containing over 450 pages of information and practical examples, as well as post-training support to aid ongoing learning and career advancement.
Frequently Asked Questions
Yes, Sprintzeal's courses are accredited by leading certification bodies and industry organizations, ensuring that participants receive high-quality training that meets industry standards and requirements.
Sprintzeal's training approach emphasizes interactive learning through practical exercises, case studies, and discussions, enabling participants to apply theoretical knowledge to real-life MDQMS scenarios.
Sprintzeal's training courses are delivered through various modes, including instructor-led classroom training, live online training, and self-paced online training, allowing participants to choose the format that best suits their learning preferences and schedule.
Sprintzeal's training courses are designed for professionals at all levels, including beginners, mid-level practitioners, and experienced professionals, seeking to enhance their skills, knowledge, and career prospects in their respective fields. Explore our wide range of courses here…
Yes, Sprintzeal offers group discounts for organizations looking to train multiple employees in ISO 13485 Lead Implementer Certification to enhance their MDQMS capabilities. Contact us for more information.
Yes, Sprintzeal offers customized training solutions tailored to meet the specific requirements of organizations, including onsite training, corporate training, and group training options, to address their unique training needs and objectives. Organizations can get in touch with us and tailor the training.
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.
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.
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