ISO 13485 Training - Kenya

ISO 13485 Training

Mastering ISO 13485 is essential for professionals in the medical device industry as it ensures compliance with rigorous quality standards. Equip yourself with the skills needed to excel in the medical device industry with The Knowledge Academy's ISO 13485 Certification Courses.

REASONS TO CHOOSE

Understand compliance with international Quality Management System standards
Learn how to maintain high-quality products and services
Identify, assess, and manage risks
Gain knowledge under the guidance of world-class training instructor
Achieve expertise with ISO 13485 Certification

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ISO 13485 Training

Duration

Online Instructor-led (1 days)

Online Self-paced (8 hours)

exam

ISO 13485 Foundation Exam

ISO 13485 Foundation Course Outline

Module 1: Introduction to ISO 13485:2016

Introduction
What is ISO 13485:2016?
Importance of ISO 13485

Module 2: An Overview of ISO 13485:2016 Requirements

Requirements of ISO 13485:2016
General Requirements
Documentation requirements
Management Responsibility
Resources
Product Realisation
Infrastructure
Risk Management

Module 3: Implementation Phases of the ISO 13485 Frameworks

Stages to Implementation
Gap Analysis
Process Mapping

Module 4: Conducting an ISO 13485 Certification Audit

Certification Audits

Module 5: The Relationship Between ISO 13485 and ISO 9001

Scope
Focus
Continual Improvement
Terminology
Differences Between the Standards
Similarities Between the Standards

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Who should attend this ISO 13485 Foundation Course?

The ISO 13485 Foundation Course is designed to provide a fundamental understanding of the ISO 13485 standard, which pertains to Quality Management Systems for medical device manufacturers and suppliers. It benefits a wide range of professionals from this course, including:

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

Prerequisites of the ISO 13485 Foundation Course

There are no formal prerequisites for this ISO 13485 Foundation Course.

ISO 13485 Foundation Course Overview

ISO 13485 sets the standards for Quality Management Systems that are crucial for organisations supplying medical devices and related services. It ensures compliance with customer and regulatory requirements, making it an essential framework for the medical device industry. This ISO 13485 Foundation Course offers a comprehensive introduction to the vital topic of ISO 13485 and its relevance in the healthcare industry.

Understanding ISO 13485 is of paramount importance for professionals in various roles. Quality Managers, Regulatory Affairs Specialists, Auditors, Manufacturing Supervisors, and individuals involved in the designing, producing, or distributing of medical devices should aim to master ISO 13485. This knowledge empowers them to ensure product quality, safety, and compliance, leading to career advancement and opportunities in the industry.

The Knowledge Academy provides 1-day ISO 13485 Foundation Training that equips delegates with essential knowledge. It covers the requirements of medical devices, the phases of implementation, and the intricacies of conducting an ISO certification audit. Delegates will gain the skills to navigate the complex medical device quality management landscape.

Course Objectives

To evaluate the expectations and requirements of the customers
To raise the quality of medical devices manufactured in a company
To enhance the organisational ability and meet customer requirements
To promote harmonisation of regulatory requirements for manufacturers
To improve the credibility and image of a company to represent compliance

Upon completing this course, delegates will benefit from a deep understanding of ISO 13485, enhancing their competence in quality management and compliance within the medical device industry. This knowledge will open doors to career progression and a more substantial contribution to the sector's growth and safety.

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What’s included in this ISO 13485 Foundation Course?

ISO 13485 Foundation Examination
World-Class Training Sessions from Experienced Instructors
ISO 13485 Foundation Certificate
Digital Delegate Pack

More information

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ISO 13485 Foundation Exam Information

To achieve the ISO 13485 Foundation, 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

More information

See dates & prices

Duration

Online Instructor-led (3 days)

Online Self-paced (24 hours)

exam

ISO 13485 Lead Implementer Exam

ISO 13485 Lead Implementer Training Course Outline

Module 1: Introduction to ISO 13485:2016

Introduction
What is ISO 13485:2016?
Benefits of Implementing ISO 13485
Applications of ISO 13485
First Steps to ISO 13485:2016 Compliance
What is a Medical Device?
Purpose of a Quality Management System
Importance of ISO 13485
Basic Principles of ISO 13485
Exercise

Module 2: ISO 13485 Clauses 1 and 2

Clause 1 – Scope
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 2 - Normative References

Module 3: ISO 13485 Clauses 3 and 4

Clause 3 - Terms and Definitions
Clause 4 - Quality Management System
- Clause 4.1 General Requirements
- Clause 4.2 Document Requirements
Exercise

Module 4: Requirements and Quality Systems

Requirements and Quality Systems
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 7 - Product Realisation
Clause 8 - Measurement, Analysis, and Improvement
Exercise

Module 5: Overview of ISO 13485:2016 Requirements

Requirements of ISO 13485:2016
General Requirements
Documentation Requirements
Management Responsibility
Resources
Product Realisation
Infrastructure
Risk Management

Module 6: Implementation Phases of the ISO 13485 Frameworks

Stages to Implementation
Gap Analysis
Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

Certification Audits
Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

Scope
Focus
Continual Improvement
Terminology
Differences Between the Standards
Similarities Between the Standards

Module 9: Internal Auditing

Internal Auditing
Internal Audit Objectives
Auditing Skills
Steps in Internal Auditing
Planning, Preparation, and Management of Audits
Internal Audit – PDCA Cycle
Types of Audit
Audit Techniques
Exercise

Module 10: Internal Audit Plan

Audit Plan
Criteria

Module 11: Audit Process

Audit Process
Conducting Process Audits
Scope
Criteria
Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

Internal Audit Evidence and Findings
Classification
Closing Report
Nonconformities
Documented Procedure
Exercise

Module 13: Roles and Responsibilities

Internal Auditor Responsibilities
Closing Meetings

Module 14: Resource Management and Product Realisation

Provision of Resources
Infrastructure
Planning and Development of Products

Module 15: ISO 13485 and Quality Management Systems

ISO 13485
Quality Management Systems (QMS)
Exercise

Module 16: Principles of Quality Management System

Principles of QMS
Exercise

Module 17: Fundamentals of Quality Management Systems

Fundamentals of Quality Management Systems

Module 18: Measurement, Analysis, and Improvement

Measurement, Analysis, and Improvement
General Requirements
Monitoring and Measurement
Control of Nonconforming Product
Performance of QMS
Analysis of Data
Improvement
Corrective Action
Preventive Action
Identification of Improvement Opportunities

Module 19: Risk Management

Risk Management
Risk Management Principle
Risk Management Process
Risk Lifecycle
Risk Management Tools
Risk Management Culture
Assessments and Control of Risk Management
Exercise

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Who should attend this ISO 13485 Lead Implementer Course?

The ISO 13485 Lead Implementer Course 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 managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes Quality Management System requirements for medical device organisations. Understanding its relevance is crucial to ensuring 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 improving an organisation's overall performance and mitigating risks associated with medical devices.

The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the knowledge and skills to effectively implement a Quality Management System for medical devices. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain and evaluate audit evidence 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 develop consultancy for a respiratory inhaler manufacturer

At the end of this training, delegates can 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.

More information

See dates & prices

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

More information

See dates & prices

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

More information

See dates & prices

Duration

Online Instructor-led (2 days)

Online Self-paced (16 hours)

ISO 13485 Internal Auditor Course Outline

Module 1: Introduction to ISO 13485:2016

Introduction
What is ISO 13485:2016?
Benefits of Implementing ISO 13485
Applications of ISO 13485
First Steps to ISO 13485:2016 Compliance
What is a Medical Device?
Purpose of a Quality Management System
Importance of ISO 13485
Basic Principles of ISO 13485
Exercise

Module 2: ISO 13485 Clauses 1 and 2

Clause 1 – Scope
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 2 - Normative References

Module 3: ISO 13485 Clauses 3 and 4

Clause 3 - Terms and Definitions
Clause 4 - Quality Management System
- Clause 4.1 General Requirements
- Clause 4.2 Document Requirements
Exercise

Module 4: Requirements and Quality Systems

Requirements and Quality Systems
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 7 - Product Realisation
Clause 8 - Measurement, Analysis, and Improvement
Exercise

Module 5: Overview of ISO 13485:2016 Requirements

Requirements of ISO 13485:2016
General Requirements
Documentation Requirements
Management Responsibility
Resources
Product Realisation
Infrastructure
Risk Management

Module 6: Implementation Phases of the ISO 13485 Frameworks

Stages to Implementation
Gap Analysis
Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

Certification Audits
Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

Scope
Focus
Continual Improvement
Terminology
Differences Between the Standards
Similarities Between the Standards

Module 9: Internal Auditing

Internal Auditing
Internal Audit Objectives
Auditing Skills
Steps in Internal Auditing
Planning, Preparation, and Management of Audits
Internal Audit – PDCA Cycle
Types of Audit
Audit Techniques
Exercise

Module 10: Internal Audit Plan

Audit Plan
Criteria

Module 11: Audit Process

Audit Process
Conducting Process Audits
Scope
Criteria
Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

Internal Audit Evidence and Findings
Classification
Closing Report
Nonconformities
Documented Procedure
Exercise

Module 13: Roles and Responsibilities

Internal Auditor Responsibilities
Closing Meetings

Module 14: Resource Management and Product Realisation

Provision of Resources
Infrastructure
Planning and Development of Products

More information

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Who should attend this ISO 13485 Internal Auditor Course?

The ISO 13485 Internal Auditor Course is a programme that allows professionals to conduct ISO 13485-based medical device Quality Management System (QMS) Internal Audits. This course can be beneficial for professionals, including:

Quality Managers
Engineers
Technicians
Regulatory Affairs Professionals
Manufacturing Managers
Compliance Officers
Medical Device Consultants

Prerequisites of the ISO 13485 Internal Auditor Course

There are no formal prerequisites for this ISO 13485 Internal Auditor Course.

ISO 13485 Internal Auditor Course Overview

ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. An ISO 13485 audit helps to identify the present state and health of your QMS and processes. It includes an independent and systematic process audit to determine QMS's conformity or nonconformity.

This training session will provide delegates with auditing techniques for Quality Management Systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will quickly get higher designations and expand their professional networks. Professionals in roles such as Quality Managers, Regulatory Affairs Specialists, Quality Control Officers, and individuals involved in internal quality audits in the medical device industry should aim to master the ISO 13485 Internal Auditor Training Course.

In this 2-day ISO 13485 Internal Auditor Training course, delegates will gain comprehensive knowledge of Quality Management Systems and how to conduct internal auditing. They will also learn about management's responsibilities for making policy and financial decisions to support QMS, how to plan a medical device, quality process audit, and documentation requirements.

Course Objectives

To carry out activities in order to achieve audit objectives
To provide products and services to medical device organisations
To enhance the organisational ability and meet customer requirements
To identify the context of a company as well as internal and external issues
To create a culture of continual improvement and improve decision-making
To maintain records and implement quality processes within an organisation

After attending this training, delegates can promote awareness of regulations and review the management to identify improvements and regulatory requirements. They will also be able to evaluate the effectiveness of the Quality Management System and document each test during processing.

More information

See dates & prices

What’s included in this ISO 13485 Internal Auditor Course?

ISO 13485 Internal Auditor Examination
World-Class Training Sessions from Experienced Instructors
ISO 13485 Internal Auditor Certificate
Digital Delegate Pack

More information

See dates & prices

More information

See dates & prices

Duration

Online Instructor-led (5 days)

Online Self-paced (40 hours)

exam

ISO 13485 Lead Auditor Exam

ISO 13485 Lead Auditor Training Course Outline

Module 1: Introduction to ISO 13485:2016

Introduction
What is ISO 13485:2016?
Benefits of Implementing ISO 13485
Applications of ISO 13485
First Steps to ISO 13485:2016 Compliance
What is a Medical Device?
Purpose of a Quality Management System
Importance of ISO 13485
Basic Principles of ISO 13485
Exercise

Module 2: ISO 13485 Clauses 1 and 2

Clause 1 – Scope
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 2 - Normative References

Module 3: ISO 13485 Clauses 3 and 4

Clause 3 - Terms and Definitions
Clause 4 - Quality Management System
Clause 4.1 General Requirements
Clause 4.2 Document Requirements
Exercise

Module 4: Requirements and Quality Systems

Requirements and Quality Systems
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 7 - Product Realisation
Clause 8 - Measurement, Analysis, and Improvement
Exercise

Module 5: Overview of ISO 13485:2016 Requirements

Requirements of ISO 13485:2016
General Requirements
Documentation Requirements
Management Responsibility
Resources
Product Realisation
Infrastructure
Risk Management

Module 6: Implementation Phases of the ISO 13485 Frameworks

Stages to Implementation
Gap Analysis
Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

Certification Audits
Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

Scope
Focus
Continual Improvement
Terminology
Differences Between the Standards
Similarities Between the Standards

Module 9: Internal Auditing

Internal Auditing
Internal Audit Objectives
Auditing Skills
Steps in Internal Auditing
Planning, Preparation, and Management of Audits
Internal Audit – PDCA Cycle
Types of Audit
Audit Techniques
Exercise

Module 10: Internal Audit Plan

Audit Plan
Criteria

Module 11: Audit Process

Audit Process
Conducting Process Audits
Scope
Criteria
Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

Internal Audit Evidence and Findings
Classification
Closing Report
Nonconformities
Documented Procedure
Exercise

Module 13: Roles and Responsibilities

Internal Auditor Responsibilities
Closing Meetings

Module 14: Resource Management and Product Realisation

Provision of Resources
Infrastructure
Planning and Development of Products

Module 15: ISO 13485 and Quality Management Systems

ISO 13485
Quality Management Systems (QMS)
Exercise

Module 16: Principles of Quality Management System

Principles of QMS
Exercise

Module 17: Fundamentals of Quality Management Systems

Fundamentals of Quality Management Systems

Module 18: Measurement, Analysis, and Improvement

Measurement, Analysis, and Improvement
General Requirements
Monitoring and Measurement
Control of Nonconforming Product
Performance of QMS
Analysis of Data
Improvement
Corrective Action
Preventive Action
Identification of Improvement Opportunities

Module 19: Risk Management

Risk Management
Risk Management Principle
Risk Management Process
Risk Lifecycle
Risk Management Tools
Risk Management Culture
Assessments and Control of Risk Management
Exercise

Module 20: Key Terms and Definitions of Lead Auditor

Key Terms Definitions

Module 21: Lead Auditor Responsibilities

Lead Auditor Responsibilities
Auditing Organisation
Auditees

Module 22: Team Leader Skills

Team Leader Skills
Exercise

Module 23: Structure and Intent of ISO 13485

Structure and Intent
Clause 5 – Management Responsibility
Clause 6 – Resource Management
Clause 7 – Product Realisation
Clause 8 – Measurement, Analysis, and Improvement

Module 24: Medical Devices, Quality, and Auditing Terminology

Medical Devices
Quality Management System
Auditing Terminology
Exercise

Module 25: Processes, Procedures, and Records

Processes
Procedure
Records

Module 26: Checklist Development

Purpose
Completed Checklist Provides
Process Based Audits
Checklist
Process Checklist

Module 27: Planning, Preparation, and Management of Audits

Planning
Preparation
Management of Audits
Exercise

Module 28: Interviewing Skills

Key Interviewing Skills
Star Technique

Module 29: Corrective Action and Verification

Overview
Corrective Action
Documented Procedure
Process

Module 30: Preventative Action

Overview
Preventive Action: Process
Exercise and Questions

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Who should attend this ISO 13485 Lead Auditor Course?

The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including:

Lead Auditors
Quality Control Managers
Regulatory Affairs Managers
Compliance Officers
Manufacturing Managers
Quality Assurance Professionals
Internal Auditors

Prerequisites of the ISO 13485 Lead Auditor Course

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of Quality Management Systems, auditing techniques, regulatory requirements, and practical experience in medical device manufacturing would significantly benefit the delegates.

ISO 13485 Lead Auditor Training Course Overview

ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations must consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training equips learners with the skills required to implement a Quality Management System for medical devices and conduct audits to ensure organisational performance. Acquiring knowledge from this training benefits organisations by streamlining processes and lowering operational challenges. Delegates pursuing this training can improve their expertise and capabilities, opening new career opportunities and potential income growth. Professionals responsible for Quality Management Systems will find mastering ISO 13485 Lead Auditor Training highly advantageous.

The Knowledge Academy provides a 5-day ISO 13485 Lead Auditor Training Course that offers a comprehensive understanding of quality management and the art of auditing systems. Delegates will delve into the implementation phases of ISO frameworks and gain expertise in gap analysis to support various clauses. They will also explore risk management, learning to map identified risks and monitor continuous improvement.

Course Objectives

To improve the quality of medical devices manufactured by a company
To promote harmonisation of regulatory requirements for manufacturers
To provide access and evidence in accordance with regulatory requirements
To engage management actively and undertake management system activities
To protect the confidentiality of all documents and information obtained in the audit
To obtain quality objectives from the manufacturer and pass them to the organisation

After completing this training, delegates can implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to take on responsibilities associated with auditing authority for the management and performance of all audit activities.

More information

See dates & prices

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

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

More information

See dates & prices

ISO 13485 Lead Auditor Exam Information

To achieve the ISO 13485 Lead Auditor, 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

More information

See dates & prices

Not sure which course to choose?

Speak to a training expert for advice if you are unsure of what course is right for you. Give us a call on +44 1344 203 999 or Enquire.

ISO 13485 Training FAQs

What does ISO 13485 mean, and why is it important?

ISO 13485 is a global standard for quality management in the medical device industry. It's vital for ensuring regulatory compliance, maintaining quality, managing risks, accessing international markets, and demonstrating a commitment to patient safety.

What are the benefits of taking these ISO 13485 Courses?

ISO 13485 Certification provides compliance with global standards, improves product quality, improves market access, effectively manages risks, boosts operational efficiency, and builds trust with stakeholders, offering a competitive edge in the medical device industry.

What does ISO 13485 Certification aim to achieve?

ISO 13485 Certification guarantees that companies in the medical device sector establish and maintain a Quality Management System aligned with global standards. This certification represents a dedication to quality, regulatory adherence, and the safe, effective production of medical devices.

Which individuals or roles require ISO 13485 Certification Training?

Professionals in the medical device industry, such as Quality Managers, Regulatory Affairs Specialists, Auditors, and those involved in Quality Management Systems, should consider ISO 13485 Training.

Are there any prerequisites to attend this ISO 13485 Training?

There are no formal prerequisites for this ISO 13485 Training.

What is the significance of holding ISO 13485 Certification?

ISO 13485 Certification is the preferred standard in the medical industry. It ensures that medical devices satisfy regulatory requirements and customer expectations. Certification provides a valuable credential, prioritising safety for professionals and patients in medical industries like clinics and hospitals.

What are the steps for implementing ISO 13485?

Implementing ISO 13485 involves a structured approach. Secure leadership commitment, define the Quality Management System's scope, analyse gaps, document processes, train employees, manage risks, perform internal audits, conduct management reviews, select a certification body, achieve certification, and continuously improve the system. This process provides regulatory compliance and product quality in the medical device industry.

What is included in this ISO 13485 Course?

This course comes with valuable training sessions led by experienced instructors, a digital delegate pack, and a certificate upon completion.

What is the duration of this ISO 13485 Training?

This course is a 1-5 day training course during which delegates participate in intensive learning sessions that cover various course topics.

Do you offer 24/7 support for this ISO 13485 Training?

Yes, The Knowledge Academy offers 24/7 support via phone & email before attending, during, and after the course. Our customer support team is available to assist and promptly resolve any issues you may encounter.

Do you provide self-paced ISO 13485 Training Courses?

The Knowledge Academy provides flexible self-paced training for this course. Self-paced training is beneficial for individuals who have an independent learning style and wish to study at their own pace and convenience.

What kind of jobs can I expect based on these ISO 13485 Training Courses?

Completing ISO 13485 Training Courses can qualify you as a Quality Assurance Manager, Regulatory Affairs Specialist, Compliance Officer, Quality Control Inspector, Auditor, and Manufacturing Engineer.

Do you provide corporate training for this ISO 13485 Certification?

Yes, we provide corporate training for this course, tailored to fit your organisation’s requirements.

What will I learn in these ISO 13485 Courses?

You will learn the skills needed to excel in the medical device industry.

Who should attend this ISO 13485 Training?

Any individual involved in auditing, designing, implementing and maintaining should attend ISO 13485 Training.

Who should I contact if i am unable to access this ISO 13485 Training online?

If you are unable to access your ISO 13485 Training, contact the support team at The Knowledge Academy via the customer service email or phone number provided on their website for prompt assistance and resolution of your issue.

Why should I take ISO 13485 Training Courses?

ISO 13485 Training helps you develop your skills and knowledge in Quality Management, Health and Safety, Information Security, Risk Management, Sustainability, and more.

What is the qualification for this ISO 13485 Certification?

The ISO 13485 Certification for individuals in the medical device industry.

What should you do after this ISO 13485 Training?

Delegates will be able to implement this ISO 13485 Training by specifying company requirements and the scope of medical devices.

What are the best ISO 13485 Training courses in Kenya?

Please see our ISO 13485 Training courses available in Kenya

Which is the best training institute/provider of ISO 13485 Training in Kenya?

The Knowledge Academy is the Leading global training provider for ISO 13485 Training.

What is the cost/training fees for ISO 13485 Training in Kenya

The training fees for ISO 13485 Training in Kenya starts from $3195

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Many delivery methods

Flexible delivery methods are available depending on your learning style.

High quality resources

Resources are included for a comprehensive learning experience.

"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

Joshua Davies, Thames Water