Corporate Group Training About Us Join as a Trainer Offers

International Organization for Standardization (ISO) 13485 Lead Implementer

ACCREDITED BY

Authorised Governing Body and Mindbel

DURATION

Online Instructor-led (3 days) English

EXAM

Complete the training from Mindbel Training and clear your certification through us

Want to skill up your team?

For corporate and in-house training

Training Calendar for International Organization for Standardization (ISO)

Filter By Month:

Training Delivery Modes

Mindbel learning offers 4 learning modes to choose

Classroom Training

Interactive sessions by expert and accredited trainers in classroom

Online Training

Industry experienced trainers led online sessions

Corporate group training for corporates

Flexible delivery methods are available depending on your learning style.

Focused One to One training

You will learn from qualified, accredited, certified and highly experienced trainers in classroom

Related Courses

International Organization for Standardization (ISO) 9001 Foundation

Online Instructor-led (1 day) English

Package price: $1,098.00

International Organization for Standardization (ISO) 9001 Lead Auditor

Online Instructor-led (5 days) English

Package price: $2,457.00

International Organization for Standardization (ISO) 9001 Internal Auditor

Online Instructor-led (2 days) English

Package price: $1,594.00

Benefits of International Organization for Standardization (ISO) 13485 Lead Implementer training with Mindbel

Average Salary

$120K

per annum

Expected Job growth rate

20%

(2016-2026)

Companies Hiring

Job Roles

  • Quality Managers and Directors
  • Regulatory Compliance Managers
  • Medical Device Manufacturers
  • QMS Consultants
  • Auditors
  • Process Owners
  • Risk Management Professionals
  • Compliance Officers
  • Anyone Involved in QMS Implementation

Benefits

  • The ISO 13485 Lead Implementer course provides a thorough understanding of the ISO 13485 standard, ensuring participants gain comprehensive knowledge of the requirements for a Medical Device Quality Management System (QMS).
  • Participants receive expert guidance from experienced instructors at Mindbel, who are well-versed in ISO standards and implementation strategies. This guidance is crucial for successful implementation within diverse organizational contexts.
  • The course equips participants with strategic implementation skills, enabling them to lead the integration of ISO 13485 into their organization's existing processes effectively.
  • Participants learn how to identify, assess, and manage risks related to the quality of medical devices, a critical aspect of ISO 13485 compliance.
  • Implementing ISO 13485 leads to enhanced quality assurance practices, fostering a culture of continuous improvement and commitment to delivering safe and effective medical devices.
  • The course ensures participants master regulatory compliance requirements, enabling organizations to navigate complex regulatory landscapes with confidence.
  • Participants gain insights into optimizing processes to meet ISO 13485 standards, resulting in improved operational efficiency and a streamlined approach to quality management.

International Organization for Standardization (ISO) 13485 Lead Implementer Training FAQs

ISO 13485 Lead Implementer course is a training program designed to provide participants with the knowledge and skills necessary to implement a medical device quality management system (QMS) in accordance with the requirements of the ISO 13485:2016 standard.
The course is intended for professionals who are involved in the implementation and maintenance of a medical device QMS, including quality managers, quality assurance personnel, and regulatory affairs specialists.
The objective of the course is to provide participants with the knowledge and skills necessary to implement a medical device QMS that meets the requirements of the ISO 13485:2016 standard.
The duration of the course varies, but it typically 3 days.
The prerequisites for attending the course vary, but participants typically should have a good understanding of quality management principles and the medical device industry.
The course topics covered typically include the structure and content of the ISO 13485 standard, the principles of quality management, and the steps involved in implementing a QMS.
The course format may vary, but it typically includes lectures, group discussions, and hands-on exercises.

The course is evaluated through assessments, exams, or practical exercises, which may be used to test participants' knowledge and understanding of the course material.  

The benefits of attending the course include gaining a better understanding of the requirements of the ISO 13485 standard, developing the knowledge and skills necessary to implement a medical device QMS, and improving the overall quality of a medical device organization.
Yes, ISO 13485 Lead Implementer certification is recognized internationally and is a highly sought-after certification in the medical device industry.

ISO 13485 Lead Implementer training is important because it equips individuals with the knowledge and skills needed to effectively lead the implementation of a medical device quality management system. 

The ISO 13485 implementation process involves planning, establishing processes and controls, documentation, training, testing, and continuous improvement.  

ISO 13485 Lead Implementer training covers the integration of risk management processes into the quality management system to ensure the safety and effectiveness of medical devices.  

ISO 13485 Lead Implementer training covers documentation requirements, including creating policies, procedures, work instructions, and records necessary for the quality management system.  

ISO 13485 Lead Implementers guide organizations in establishing control measures to monitor processes, prevent non-conformities, and ensure the consistency of product quality.  

Top

Mindbel

#73, Karnataka Layout HBCS, 2nd Stage, 3rd Main Road, Bangalore 560079, India

1095 Sugar View Dr Ste 500, Sheridan, WY 82801, USA

Call Us

+91-7483337319

Email Address

support@mindbel.com

Join Us

As a Trainer

Corporate Solution

Corporate Group Training

We Accept

Company

Popular Training Categories
Popular Certification Courses

DISCLAIMER: The following disclaimer outlines the terms and conditions of use for the Mindbel Online Training Portal. By accessing and using our website, you agree to comply with the terms and conditions set forth in this disclaimer. If you do not agree to the terms and conditions, you should not use this website.

The names, trademarks, logos, and brands displayed on the Mindbel Online Training Portal are the property of their respective owners. The use of these names, trademarks, logos, and brands does not imply endorsement or affiliation with Mindbel, unless explicitly stated. The use of these names, trademarks, logos, and brands is solely for the purpose of identifying the products and services offered by their respective owners.

The content, information, and materials on the Mindbel Online Training Portal are provided for informational purposes only. We make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

Mindbel shall not be liable for any loss or damage arising out of or in connection with the use of the Mindbel Online Training Portal or any information, products, services, or related graphics contained on the website. This includes without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.

The Mindbel Online Training Portal may contain links to other websites which are not under the control of Mindbel. We have no control over the nature, content, and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.

The Mindbel Online Training Portal is provided on an "as is" basis without any representations or warranties, express or implied. Mindbel makes no representations or warranties in relation to the Mindbel Online Training Portal or the information and materials provided on the website.

Copyright © Mindbel 2022-2023 All rights reserved.