ISO 13485 Training - India

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 Training in India.

REASONS TO CHOOSE

Ensure compliance with international quality management system standards
Enhance your organization's ability to maintain high-quality products and services
Develop skills to identify, assess, and manage risks associated with medical devices
Expand your knowledge under the guidance of world-class training instructors
Validate your skills with the ISO 13485 Training in India

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ISO 13485 Training

Duration

Online Instructor-led (1 days)

Classroom (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: Overview of ISO 13485:2016 Requirements

Requirements of ISO 13485:2016
General Requirements
Documentation requirements
Management Responsibility
Resources
Product Realization
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: Relationship Between ISO 13485 and ISO 9001

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

More information

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Who should attend this ISO 13485 Foundation Course?

The ISO 13485 Foundation Course in India 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, 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

The ISO 13485 sets the standards for quality management systems that are crucial for organizations supplying medical devices and related services. It ensures compliance with customer and regulatory requirements, making it an indispensable framework for the medical device industry. This ISO 13485 Foundation Course in India 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 India in various roles. Quality Managers, Regulatory Affairs Specialists, Auditors, Manufacturing Supervisors, and individuals involved in the design, production, or distribution 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's 1-day ISO 13485 Training in India 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 needed to navigate the complex landscape of medical device quality management.

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 organizational ability and meet customer requirements
To promote harmonization of regulatory requirements for manufacturers
To improve the credibility and image of a company to represent compliance

Upon completion of this ISO 13485 Training in India, 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 stronger 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

See dates & prices

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)

Classroom (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 Realization
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 Realization
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 Realization

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 in India 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 in India is a course that introduces delegates to the aspects of managing quality in the medical device industry. ISO 13485 Certification is a globally recognized standard that establishes quality management system requirements for organizations that produce medical devices. Understanding its relevance is crucial, as it ensures that organizations 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 in India. 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 organization's overall performance and mitigate risks associated with medical devices.

The 3-day ISO 13485 Training Course in India 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 harmonization 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 in India, 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 analyze 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)

Classroom (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 Realization
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 Realization
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 Audits
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 Realization

Provision of Resources
Infrastructure
Planning and Development of Products

More information

See dates & prices

Who should attend this ISO 13485 Internal Auditor Course?

The ISO 13485 Internal Auditor Course in India 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 organization 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 comprises an independent and systematic process audit to determine QMS's conformity or nonconformity.

This training session equips learners with the auditing techniques of quality management systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will get higher designations and expand their professional networks within a short period. 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 India.

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

Course Objectives:

To carry out activities in order to achieve audit objectives
To provide products and services to medical device organizations
To enhance the organizational 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 organization

After attending this training in India, delegates will be able to 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)

Classroom (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 Realization
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 Realization
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 Audits
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 Realization

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 Organization
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 Realization
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

More information

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Who should attend this ISO 13485 Lead Auditor Course?

The ISO 13485 Lead Auditor Course in India 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, and regulatory requirements, along with practical experience in medical device manufacturing, would greatly benefit the delegates.

ISO 13485 Lead Auditor Training Course Overview

ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organizations need to consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training in India equips learners with the skills required for implementing a quality management system for medical devices and conducting audits to ensure organizational performance.

Acquiring knowledge from this ISO 13485 Training benefits organizations by streamlining processes and reducing operational challenges. Individuals in India pursuing this training can enhance their expertise and capabilities, opening new career opportunities and potential income growth. Professionals in roles that are responsible for quality management systems, should aspire to master ISO 13485 Lead Auditor training.

The Knowledge Academy's 5-day ISO 13485 Lead Auditor Training Course in India 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 how to map identified risks and monitor continuous improvement

Course Objectives:

To improve the quality of medical devices manufactured by a company
To promote harmonization 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 organization

After completing this training in India, 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 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 +91 8037244591 or Enquire.

ISO 13485 Training FAQs

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

ISO 13485 is an international standard specifying requirements for a quality management system (QMS) in the design, development, and manufacturing of medical devices. It ensures compliance with regulatory requirements and emphasizes the importance of product safety and quality.

Is it mandatory to have ISO 13485 Certification?

ISO 13485 is crucial for organizations in the medical device industry as it establishes a framework for maintaining quality, safety, and regulatory compliance. It enhances customer confidence, supports market access, and mitigates risks associated with medical device production.

What is the purpose of ISO 13485 Training?

While ISO 13485 Course is not mandatory, it is highly recommended for organizations involved in the medical device industry. Certification demonstrates a commitment to quality and compliance, making it an asset in a competitive market.

Who needs ISO 13485 Training?

ISO 13485 Training Courses aims to provide professionals with the knowledge and skills necessary to implement and maintain a compliant quality management system for medical devices. It ensures understanding of ISO 13485 requirements and best practices.

What are the prerequisites needed for these ISO 13485 Certification Training Courses?

There are no formal prerequisites to attend these ISO 13485 Courses.

Which individuals or roles require ISO 13485 Certification Training?

Individuals involved in quality assurance, regulatory affairs, product development, manufacturing, and top management in medical device companies often require ISO 13485 Certification training to fulfill their responsibilities effectively.

What is the significance of holding ISO 13485 Certification?

ISO 13485 Certification signifies that an organization complies with international standards, instilling confidence in stakeholders regarding the quality, safety, and regulatory conformity of medical devices. It can open new market opportunities and enhance credibility.

What are the steps for implementing ISO 13485?

Implementing ISO 13485 involves defining processes, establishing a quality management system, conducting risk assessments, ensuring regulatory compliance, and regularly reviewing and improving the system. It requires commitment from top management and collaboration across departments.

What are the best ISO 13485 Training courses in India?

Please see our ISO 13485 Training courses available in India

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

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

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

The training fees for ISO 13485 Training in India starts from INR64995

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"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