Title: ISO 13485 Implementer
Duration: 2 Days
Certification Exam(s): ISO 13485 Implementer
Accredited: No
Pre-course Reading: None
Rating: 4.5 Stars
Dates and Prices Course Information
ISO 13485 is a quality standard for the manufacture and design of medical devices. This ISO 13485 course guides on the standard in detail, delivering the understanding of its clauses helping the businesses in improving manufacturing quality while reducing defects.
Budget constraints? Just get in touch and we will do our best to assist!
There are no training slots currently available for Virtual Classroom method of delivery. Why not check Classroom slots?
Alternatively, please Contact us and we may be able to help you.
There are no training slots currently available for Virtual Classroom method of delivery. Why not check Classroom slots?
Alternatively, please Contact us and we may be able to help you.
There are no training slots currently available for Classroom method of delivery. Why not check Virtual Classroom slots?
Alternatively, please Contact us and we may be able to help you.
ISO 13485:2016 is an international standard that defines the requirements of quality management systems for organisations that design, develop, manufacture, and implement medical devices. It also includes services regarding design and development of material or component parts used in the medical devices. The most recent version of the standard was published in March 2016.
Following modules/ topics will be covered in ISO 13485 course:
Module 1: Introduction to ISO 13485:2016
Module 2: A Overview of ISO 13485:2016 Requirements
Module 3: Implementation Phases of the ISO 13485 Frameworks
Who Should Attend?
This course is suitable for professionals involved in the manufacture and design of medical devices or related field.
There are no pre-requisites for attending this course.
Virtual classroom trainings are held using video conferencing software. A trainer leads the class for the duration of course. Delegates may attend the session using PC, laptop or tablets.
Minimum of 20Mbps is recommended internet speed.
No, this course is not accredited by any certification body.
Tecknologia trainers are highly experienced practitioners with excellent training delivery capabilities. Our trainers are accredited by various bodies for relevant training deliveries.
This instructor lead course includes following:
Refreshments (tea/ coffee) will be provided free at venue for classroom courses.
ISO 13485:2016 is an international standard that defines the requirements of quality management systems for organisations that design, develop, manufacture, and implement medical devices. It also includes services regarding design and development of material or component parts used in the medical devices. The most recent version of the standard was published in March 2016.
51236TKSKU /webroot/uploads/ISO-13485.webpThe course itself was really perfectly executed by Tecknologia. Very good training materials, a very professional and experienced trainer and perfect scheduling of the lessons. Based on the training it was possible to pass the exams with very good results. I’m very happy to having chosen Tecknologia as training partner.
A very well organised course that covered all the relevant aspects of the topic and prepared you well for the exam. The instructor has a deep knowledge of the field and he answered all questions with clarity. Registration was smooth, delivery of the book (hard copy) was quick and everything was done very professionally.
I would say that Tecknologia is extremely professional, they have great trainers with sound knowledge of the subject. All the team members cleared the APMG exam with flying nos due to the commitment and coverage done by the trainer during the coursework. I highly recommend Tecknologia for professional certification and be part of our Agile Journey.
Guidelines on what pre-reading and studying was needed before and during class was very clear throughout to ensure you know how to make most use out of the study materials and which aspects to concentrate on. Passed the exam on first attempt. Thank you Tecknologia, for a fun and pleasant learning experience!
This was my second course with Tecknologia and my experience has been excellent like the earlier one. We had interactive sessions, real-life examples, and solutions that really help in building a deep understanding of the underlying mechanics of Change management.
Great course. Trainer was able to handle complex scenarios and provide practical guidance throughout. Highly recommend!
Very interesting and useful course with mix of theory and lots of practical examples. The content was presented in an enthusiastic way by the Trainer, exhibited excellent presentation skills with plenty of opportunities to ask questions.
Excellent trainer, really knowledgeable and had a great deal of patience with the variety of questions the team had. Enjoyed the course and its content!
We had Teknologia do on site training of PRINCE2 Foundation and Practitioner for a group of ten people in Denmark, course language English. Tecknologia delivered a competent and thorough training at a resonable price.Absolutely recommended by me.
Excellent teacher! Creating a trustful atmosphere and good energy in the class room - entailing good discussion and here through better understanding of (complicated) stuff. Thanks!
The trainer conducted a good MSP training as preparation for the foundation and practitioner exams. We also had time to discuss the applicability and tailoring of the theory to programme management in our organization.
Our trainer added the right level of information to the books, to understand the themes, Principles and processes. Next to that he made sure the attendees were prepared for the exams...!
The course was quite interactive session and our trainer happily answered all our questions and equipped us with the knowledge mapping to real time scenario. This helps me to understand the concepts and made me prepared for the certification exams.
I attended the 5-day training in PRINCE2 from Tecknologia, given by a fantastic Trainer. A good mix of theoretical lessons and experiences from the field. Super experience!!!
I attended the 2-day training in Agile programme management (APgM). The trainer is very knowledgable, explains all the concepts at a very concrete level, runs a good pace and is very flexible in answering all question.
My trainer was incredibly knowledgeable and helpful throughout the entire course. I didn't feel hurried to get through the material and felt supported the entire time with any questions I had.
The whole process from start to finish was seamless and I will be 100% recommending Tecknologia to my colleagues to undertake future training courses. Thank you again to Waseem and the team for providing such a tailored service.
The way the course was led and the management of everything (including paperwork we needed for procurement purposes) all worked seamlessly.
PRINCE2 training had a very systematic approach which helped with an understanding of all necessary topics to cover the material needed for the exam.
Our Tecknologia instructor was very knowledgeable in explaining a difficult topic like PRINCE2 project management. During the course he introduced the main topics of project management to a very diverse audience, and pointed out some subtle aspects that could be applied in our daily work.
Prince2 book is a torture to read and comprehend. Instructor however was knowledgable in teaching delivery methods to make information understandable to multitude of attendees. Kept the right voice tone not to make it monotonous, good speed of delivery and provided easy to understand framework of how to pass the exam.
The trainer was very patient and professional explaining all details and answering all questions. I felt really prepared for certification exams after taking the course. Really looking forward for next course provided by TECKNOLOGIA
Great customer service, customer relationships. The course was clearly structured and easily understandable. I can only recommend the company and the trainers.
All round excellent experience. Easy booking process, 1-2-1 support during the sales and after sales process, and a well delivered course.
I was well equipped to conduct my foundation and practitioner exams and achieve high passes for both, first time. I'm very impressed with professional delivery that is both inspiring and motivating.
Really professional, extremely helpful and maintained a relaxed learning environment.
Very good experience with high flexibilty on scheduling. The training setup was great and the trainer had vast experience and knowledge on the subject. Highly recommend!
Competent trainer. Clear communication and logistic. Well done training!
Just finished training today. Excellent trainer. Really enjoyed it. Learnt a lot.
Very good session, hopefully, I have gained and retained enough knowledge to pass my practitioner exam.
Ggreat trainer, very personable and patient. Great delivery of content!
Good engaging course, friendly trainer.
The trainer was very good – using easy English, making sure everybody understand the content; good balance with brakes – not too many, not too few; overall good training despite extremely theoretical and extensive training subject.
Fantastic trainer, the 4-day Agile PM course was very informative and all concepts were explained comprehensively, with plenty of opportunity to ask questions and practice with team-based case studies.
Highly informative and intelligent trainer. He created a respectful and great environment to learn and was happy to answer all questions asked by the team. What a pleasure!
Very knowledgeable and great presenter.
Jus finished M_o_R 4. Our instructor was amazing! made the learning experience more enjoyable. Great experience!
Highly accomplished tutor and delivered the course in a professional & comfortable manner. Tecknologia, are definitely a company that you should be using for your training needs. A*
It was amazing experience with Tecknologia and Master Trainer who tried to explain each and every module in details. I would love to have more trainings from them.
Great course, 100% pass record to date. Great teacher I can not recommend this highly enough.
I participated in a 5 day Prince2 training and passed the exams for the Foundation and Practitioner parts (which were definitely not the easiest ones). The training delivery was super professional and the trainer was very patient and competent. I can only recommend it to the others.
Second training with Tecknologia and I would do it again if needed. No one give you a 100% guarantee that you will pass, but the company conducts training in such a way that the chance of success is high.
Very professional and structured PRINCE2 course.
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