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
Frankfurt am Main
Live Online Training
€ 1896 €2844
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- 24x7 learner assistance and support
Classroom Training
€ 3799 €5699
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- Access to Course and Study Materials
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Corporate Training
- We can customise the training
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- 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
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Logan DeSanto 5
Feb 29th, 24
System Engineer
Overall Sprintzeal Comptia A+ was great, they helped me a lot just learning stuff I would have never learned otherwise, one way they could improve is by starting a bit earlier in IT, like just giving basic knowledge and vocabulary that we should know. Otherwise once we learned everything it was pretty easy to grasp.
Edward Lee 5
May 21st, 24
Senior Manager
Lean Six Sigma Black Belt
Informative and practical approach of training session. Emphasizing more on the relevant tools that can be use depending on the project that you are working on.
Karen Mummaw 5
Jan 19th, 24
Chief Operating Officer at The Prospective Group
It was an excellent Bootcamp that provided a solid foundation/framework for PMP. I was hesitant to take a virtual course, but the limited size of the class and the excellent instruction made me a believer in virtual classes.
Pamela Sue Raitz-Rocho 5
Jan 17th, 24
System Engineer
I took the certification program CompTIA security+. I really enjoyed the course. The facilitator was very knowledgeable and thoughtful in explaining concepts. I do wish there were more live sessions. I don't think 8 is enough to fully prepare for the CompTia test.
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.
Tony Mathew 5
Feb 14th, 24
Senior Program Manager
The training was very worthwhile and Mahesh the trainer was extremely knowledgeable. He provided real-world examples that assisted greatly. The content was well written, understandable and valuable. I would highly recommend this company and class for others. Lastly, the sign-up and coordination for the class was good as well.
Lance Meyer 5
Oct 20th, 24
Network Administrator
Great practical application and 1-1 training
The training was virtual and thus I was expecting a 'room' full of people. However it was just the instructor (Sonu Verma) and I. This made it much easier to tailor the instruction to my background and learning style and to go faster through material that I was already comfortable with.
Hakima EL-GAMAH 5
Jun 19th, 24
Senior Business Analyst
I participated to Lean Six Sigma Black Belt Training with Sprintzeal. The instructor, Swati Kondappali, is very knowledgeable and has a lot of experiences to share. The presentqtion is well structure and Swati took always the time to explain the techniques and tools with exemples through the full course. Thank you!
Jonah Carroll 4
Oct 1st, 24
IT Support Tier 1
The trainer did well covering a wide range of topics in 4 days, although I would have liked some more real-life representations of what was being shown.Perhaps VMs, or examples of how viruses work in a real-to-life environment.Aside from that, I thought the course was very informative and helped build a framework for an understanding of Security+. We were also provided 12 hours of CompTIA labs that I think will be a HUGE help.
Regina Ogbone 5
Jul 11th, 24
Senior System Engineer
"I've never completed a course like this before (remotely) and 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. The instructor was very knowledgeable and provided a wealth of information about the current version of CompTIA Security+. All my questions were answered and the class interaction was very good. I loved the fact that even though I was in a class with other people, the actual physical space was quiet and very conducive to learning! Thank you.
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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