ISO 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
Monterey Park CA
Live Online Training
$ 1996 $2994
- Live Online Training by Industry Experts
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- Flexible Learning Modes for Efficiency
- 24x7 learner assistance and support
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- Pay after the training completion
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Course Agenda
Company Brochure
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
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Susan Combs-Foushee 5
Dec 2nd, 24
Sales Representative at Atlantic Corporate Interiors
Sprintzeal's preparatory course for PMI's "Project Management Professional" certification provides the knowledge base and test-taking strategies needed to pass the exam.The course fee includes all the study materials and the instructor guidance needed to succeed!
I highly recommend this experience and will consider taking additional Sprintzeal training courses in the future.
Murali Thimmegowda 5
Mar 23rd, 24
Senior Consultant at Capgemini
PSM 1 training by Sprintzeal was excellent. The trainer was very good and provided excellent training in a simple manner with lots of workshops, practices, and scenarios. I recommend Sprintzeal for PSM /CSM training.
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Sean Allen 5
Mar 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.
Mitul Prafulbhai Bharwad 5
May 17th, 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.
Puja Sajja 5
Jan 14th, 25
Sr Manager - Enterprise Data and Machine Learning Engineer
Toshal was very experienced, patient and energetic trainer. I'd recommend him to every one who wants to get comfortable to get hands on with AWS services!
Thank you Sprintzeal for a very helpful training!
Liza Barrick 4
Oct 15th, 24
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.
David Carnell 5
Jan 18th, 25
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.
Sarochin Tollette, BSEE, Certified ScrumMaster 5
Feb 12th, 25
Program Manager | Senior Technical Project Manager | Software Engineering Manager | Collaborator | Problem Solver
I'm glad I discovered SprintZeal on my journey to getting the PMP Certification and Lean Six Sigma Green Belt Certification. Their PMP Certification Exam Prep course and resources (videos, practice exams) are very effective and helpful. The teachers and support staff are top-of-the-line. When I have questions, I get almost instantaneous replies from the support focal (even during the holidays). The Lean Six Sigma Green Belt Certification on-line course is easy to comprehend. The on-line course gives me flexibility as I can take it anytime, on my own schedule. I look forward to taking the exams and getting my certification!
Christi Sifri 4
Oct 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
Andy O'Meagher 5
May 31st, 24
IT Level 1 & 2 Support
I have attended ITIL® 4 Foundation by Sprintzeal that was really helpful to get introduction to the matter and get prepared to the exam. The trainer has demonstrated his ability to emphasize the most crucial points of ITIL 4, the communication was easy and straight forward, all the queries have been answered properly with real life examples.
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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