+1 315 666 4295ISO 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
Boston MA
Live Online Training
$ 1996 $2994
- Live Online Training by Industry Experts
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- 24x7 learner assistance and support
Classroom Training
$ 3992 $5988
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Corporate Training
- We can customise the training
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- 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
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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.
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Andy O'Meagher 5
May 16th, 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.
Aaron Coleman 5
Apr 13th, 24
Facility Manager
Jason and Shane were phenomenal. I scheduled the bootcamp and went through the training. I had a hiccup during the training and was unable to complete a portion. Jason made all of the resources available to me and accommodated me in moving forward. Jason from Sprintzeal was helpful from the start and through the finish of the process. Thank you all so much! You are all that you advertise and so much more. 100% great training and service!
Benny Rodriguez 5
Aug 9th, 24
Senior System Enginner
The session was awesome, interactive, and very educational all over. I enjoed my CompTIA Network+ session with the trainer
Nicole Gentz 5
Mar 19th, 24
Development Team Manager at Stoneridge Software
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!
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
Safiqul Sarkar 4
Mar 18th, 24
Certified Microsoft Engineer
Concepts have been explain with real world examples. Key is to forget organizational practices when opting for ITIL and keep and open mind about the concepts and not mix it.
It was a great learning experience
Bernadette Vida 5
Mar 12th, 24
IT Program Manager, Business Owner
Dana is an excellent instructor. He had a lot of test taking and industry experience. I noticed that the power point and test material references the 5th edition. For example, the reference to Quality Audit which is in the 6th Edition called Quality Assurance. Dana was able to point these out and reduce confusion.
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.
Shaun McElrath 5
Feb 17th, 24
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.
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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