ISO 13485 Lead Implementer - United Kingdom

Who should attend this ISO 13485 Lead Implementer Course?

The ISO 13485 Lead Implementer Course programme gives employees the knowledge and skills they need to lead the implementation and management of an ISO 13485-based Quality Management System for medical devices. Below are some professionals who can benefit from this course:

• Quality Managers
• Regulatory Affairs Professionals
• Product Managers
• Compliance Officers
• Manufacturing Managers
• Quality Assurance Professionals
• Internal Auditors

Prerequisites of the ISO 13485 Lead Implementer Course

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates

ISO 13485 Lead Implementer Training Course Overview

ISO 13485 Lead Implementer Training is a course that introduces delegates to the aspects of managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes quality management system requirements for organisations that produce medical devices. Understanding its relevance is crucial, as it ensures that organisations consistently meet customer and regulatory requirements in the medical device field.

Mastering ISO 13485 is essential for anyone responsible for implementing and managing quality management systems in the medical device industry. It provides a valuable credential for individuals dedicated to quality assurance and regulatory compliance, opening opportunities for high-profile jobs and enhanced earnings. Its importance lies in its ability to enhance an organisation's overall performance and mitigate risks associated with medical devices.

The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the necessary knowledge and skills to implement a quality management system for medical devices effectively. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain audit evidence and evaluate it objectively. They will also learn how to control nonconforming products identified during the inspection process.

Course Objectives:

• To evaluate the expectations and requirements of the customers
• To improve the quality of medical devices manufactured by a company
• To promote harmonisation of regulatory requirements for manufacturers
• To enhance the credibility and image of a company to represent compliance
• To engage management actively and undertake management system activities
• To design and development consultancy for a respiratory inhaler manufacturer

At the end of this training, delegates will be able to implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to analyse the data and implement identified opportunities for improvement.

What’s included in this ISO 13485 Lead Implementer Course?

• ISO 13485 Lead Implementer Examination
• World-Class Training Sessions from Experienced Instructors 
• ISO 13485 Lead Implementer Certificate
• Digital Delegate Pack

ISO 13485 Lead Implementer Exam Information

To achieve the ISO 13485 Lead Implementer, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice  
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book