ISO 13485 Lead Implementer Training
As an international standard, ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal. However, ISO 13485 can also be operated by other parties such as certification bodies which can assist in the certification processes. ISO 13485 serves as a tool for organizations to develop and retain their processes efficiently. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers.
Benefits of ISO 13485
By becoming an ISO 13485 certified professional, you will be able to:
- Increase the number of job opportunities
- Create new business connections
- Gain competitive advantage
- Increase effectiveness and lower costs
- Offer expertise on improving work processes
- Offer safer and more efficient medical devices
- Increase customer satisfaction
How do I get started with ISO 13485 Training?
If you are willing to take the challenge of obtaining an ISO 13485 certification, our experts will ensure a qualitative experience where your needs will be met, and you will become part of our global network.
ISO 13485 Lead Implementer
Why should you attend?
- ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
- After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.
Who should attend?
- Managers or consultants involved in Medical Devices Quality Management
- Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
- Individuals responsible for maintaining conformance with MDQMS requirements
- MDQMS team members
Learning objectives
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
- Learn how to interpret the ISO 13485 requirements in the specific context of an organization
- Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
- Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
Educational approach
- This training is based on both theory and best practices used in the implementation of a MDQMS
- Lecture sessions are illustrated with examples based on case studies
- Practical exercises are based on a case study which includes role playing and discussions
- Practice tests are similar to the Certification Exam
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Job Interview Question Answers
- Security Job Interview Questions
- Job Interview Checklist
- General Job Interview Questions
- What to wear for Best Job Interview Attire
- Behavioral Job Interview
- Information Technology Job Interview
International Fee: 650USD
Job Interview Preparation (Soft Skills Questions & Answers)
- Tough Open-Ended Job Interview Questions
- What to Wear for Best Job Interview Attire
- Job Interview Question- What are You Passionate About?
- How to Prepare for a Job Promotion Interview
🎥 Your FREE eLEARNING Courses (Click Here)
Internships, Freelance and Full-Time Work opportunities
Flexible Class Options
- Week End Classes For Professionals SAT | SUN
- Corporate Group Trainings Available
- Online Classes – Live Virtual Class (L.V.C), Online Training
Job Interview Preparation (Soft Skills Questions & Answers)
- Tough Open-Ended Job Interview Questions
- What to Wear for Best Job Interview Attire
- Job Interview Question- What are You Passionate About?
- How to Prepare for a Job Promotion Interview
🎥 Your FREE eLEARNING Courses (Click Here)
Internships, Freelance and Full-Time Work opportunities
Flexible Class Options
- Week End Classes For Professionals SAT | SUN
- Corporate Group Trainings Available
- Online Classes – Live Virtual Class (L.V.C), Online Training
Related Courses
ISO 27032 Lead Cyber Security Manager (Online Class)
ISO 27001 Information Security Management System (ISMS) Lead Auditor Program
ISO 22301 – Lead Auditor – Business Continuity Management System (BCMS)
ISO 9001:2015 – Lead Auditor Training Course
ISO 27001 Information Security Management Systems – ISMS Foundation
