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
Melbourne VIC
Live Online Training
A$ 2874 A$4311
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- 24x7 learner assistance and support
Classroom Training
A$ 5759 A$8638
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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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- 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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Sean J Davis 5
Feb 17th, 24
MAJ, AV Deputy G3 Aviation 1st Cavalry Division
I just finished the PMP Boot Camp and it was an excellent experience. Mr. Wood went above and beyond assisting me with enrollment and without him I would have missed out on this great opportunity. My instructor Gabi was phenomenal! She was very patient and brought a wealth of real-world experience that provided clarity throughout the training. I had numerous instructor in my life but Gabi is one of the best. I would recommend the Sprintzeal PMP Boot Camp if you are interested in pursuing employment in this field. I and prepare to put my newly learned skills to use after this great learning experience.
Lynne Colley 5
Jan 19th, 24
Clarity | Action = Corporate Real Estate and FM Consulting Coach
Best training ever. Muhammad Faisal was just the best tutor. By the end of 4 days training from zero start I was already achieving over 60 percent and then just had to follow up with the study plan and go ahead with the momentum. Nothing was too much trouble. Extremely supportive tutor who also coached me with the application process and heaps of tips for the exam. I know I am ready and I will come back and let you know when I pass in the next month. for sure.
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.
Victor Cobile 5
Sep 9th, 24
Management and Program Analyst at Logistics Readiness Center
Mr. Biswa has been a very thorough instructor providing a very comprehensive training on Program Management. It has been a pleasure learning from him and look forward to taking more courses under Sprintzeal for related topics on Program Management. I will take what I have learned from him and Sprintzeal to my workplace and maybe apply some of the lessons in the area of Procurement Management. I feel also that I am maybe 60% percent ready to take the exam but will be close to 100% by the time I read more course materials and study for it. Thank you for the learning experience and look forward to learning some more.
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.
David Carnell 5
Jan 18th, 24
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.
Puja Sajja 5
Jan 30th, 24
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!
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.
Dale Hansen 5
Oct 23rd, 24
Executive Assistant to the CEO & IT Administrator
Lean Six Sigma Black Belt
Nice to take session with Ashish as he has very good insight on topics both theoretical and hands on. Also, he has a lot of experiences to share.
Roger Cleuskens 5
Feb 13th, 24
IT Support Engineer
It was a good learning experience connected to practical aspects and real projects. I enjoed my CompTIA network+ session with the trainer.
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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