ISO 13485 Foundation Certification Training in India

As per International Standards

  • Online/Group Sessions
  • 1 Day
  • Examination Included
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ISO 13485 Foundation Certification Training in other cities of India

ISO 13485 quality management system for medical devices

ISO 13485 Foundation Certification in India is awarded to individuals well-versed in developing a quality management system for medical devices. The ISO 13485 Standard emphasizes on implementing Medical Device Quality Management System as per the requirements. Businesses that manufacture medical devices are necessitated to implement the ISO standard. Organizations that are certified with ISO 13485 execute the MDQMS to showcase the required quality of medical devices. Professionals certified with ISO 13485 Foundation Certification in India demonstrate their skills in managing the MDQMS instilled within the organization. The ISO certification is internationally recognized, offering ample opportunities for professionals pursuing a career in this field. Any individual can pursue the ISO 13485 Foundation Certification as there are no prerequisites.

ISO 13485 Foundation Certification Training in India

ISO 13485 Foundation Training is offered by Unichrone across various cities of India. Aspirants acquire a comprehensive understanding of ISO 13485 standard and its requirements. The ISO 13485 Foundation Training in India helps aspirants to master the processes involved in developing and maintaining an MDQMS. In addition, aspirants learn about the policies, procedures, performance measurements and continual improvement for MDQMS. Professionals who are involved in medical device quality management can pursue the certification and enhance their knowledge. Furthermore, certified ISO 13485 professionals can enhance their career options with the certification. The ISO 13485 Foundation Certification holders are highly sought-after in the medical device industry.

Key Features of ISO 13485 Training in India

ISO 13485 Foundation Certification Training in India is conducted through various methods. Professionals can choose either the online method or the in-class method and attend the sessions at their convenience. Expert trainers engage in offering real-time insights into the field. In addition, aspirants analyze the standard and its correlation with other frameworks. Furthermore, aspirants master the approaches and techniques for managing the MDQMS. On completion of the training sessions, aspirants are required to attempt the ISO 13485 Foundation Exam. Professionals who clear the exam can attain their ISO 13485 Certification.

  • 1 Day Interactive Instructor –led Online Classroom or Group Training
  • Course study materials designed by subject matter experts
  • Mock Tests to prepare in a best way
  • Highly qualified & accredited trainers with vast experience
  • Enrich with Industry best practices and case studies
  • ISO 13485 Foundation Course adhered with International Standards
  • End-to-end support via phone, mail, and chat
  • Convenient Weekday/Weekend ISO 13485 Foundation Training Course schedule
Corporate Group Training
  • Customized Training
  • Live Instructor-led
  • Onsite / Online
  • Flexible Dates
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ISO 13485 Foundation Exam Format
Exam Name ISO 13485 Foundation
Exam Cost Included in Training Fee
Exam Format Multiple Choice, Open Book Exam
Total Questions 30 Questions
Passing Score 70% passing marks
Exam Duration 1 hour

ISO 13485 Foundation Certification Benefits

Higher Salary

With this renowned credential, aspirants earn higher salary packages when compared to non-certified professionals in the field

Individual accomplishments

Aspirants can look for higher career prospects at an early stage in their life with the most esteemed certification

Gain credibility

Owning the certification makes it easier to earn the trust and respect of professionals working in the same field

Rigorous study plan

The course content is prescribed as per the exam requirements, covering the necessary topics to ace the exam in the first attempt

Diverse job roles

Attaining the certification enhances the spirit of individuals to pursue diverse job roles in the organization

Sophisticated skillset

With this certification, individuals acquire refined skills and techniques required to play their part in an organization

ISO 13485 Foundation Training Course Curriculum

Frequently Asked Questions

How is the ISO 13485 Foundation Training conducted in India?

The ISO 13485 Foundation Training in India is conducted in live online instructor-led method and in-class method by Unichrone.

Why do I need ISO 13485 Foundation Training in India?

The ISO 13485 Foundation Training is hosted by expert trainers. Aspirants can reap the benefits of practical insights and apply the best practices. This in turn helps businesses to implement and manage MDQMS without any hassles.

Why should I opt for online ISO 13485 Foundation Training in India?

The online ISO 13485 Foundation Training is conducted in a live manner. Aspirants, as well as trainers, log in at the same time for the session. This helps aspirants to attend the program from their homes or office rather than traveling to the training venue.

What is the duration of ISO 13485 Foundation Training in India?

The ISO 13485 Foundation Training session is conducted for a day across various cities of India.

Is there any certification provided for ISO 13485 Foundation Certification Training?

Yes, candidates get a course completion certificate after completing ISO 13485 Foundation Certification Training.

Is self-study better than live online instructor-led training for ISO 13485 Foundation Certification?

It is difficult for candidates to understand the concepts of ISO 13485 through self-paced learning. However, live Online training offers candidates the opportunity to interact with instructors and clear their doubts. This assists candidates in a better understanding of ISO 13485 standards.

How many levels are there in ISO 13485 course?

There are three levels in ISO 13485 course: ISO 13485 Foundation course, ISO 13485 Lead Auditor course, and ISO 13485 Lead Implementer course.

Do you provide a mock test for ISO 13485 Foundation Certification Training in India?

Yes, Unichrone provides a mock test for ISO 13485 Foundation Certification Training in India.

What is the skill set acquired during ISO 13485 Foundation Certification Training?

Candidates will gain skills in implementing ISO 13485 standards and establishing a Medical Devices Quality Management System. Furthermore, candidates gain knowledge in analyzing and monitoring the functioning of MDQMS.

What companies need ISO 13485 standard?

Organizations specialized in designing, manufacturing, installing, and servicing various medical devices need ISO 13485 standards.

What countries do not apply ISO 13485:2016 standards?

Countries except for Europe, Canada, USA, Japan, Australia, Singapore, and Malaysia do not apply ISO 13485:2016 standards.

What is the format of ISO 13485 Foundation Exam?

The ISO 13485 Foundation exam comprises multiple-choice questions which have to be answered within 1 hour by aspirants.

How can I pass the ISO 13485 Foundation Exam in India?

Aspirants need to score 70% or more to pass the Foundation Exam and obtain their certification.

Is there a re-examination policy?

Yes, aspirants can retake the exam within 6 months from the date of the initial attempt.

Is there any separate fee for ISO 13485 Foundation Exam in India?

No, candidates do not have to pay a separate fee for ISO 13485 Foundation Exam. It is included in the ISO 13485 Foundation Training in India.

Is it possible to get a certificate without attempting ISO 13485 Foundation Exam?

No, candidates must attend and pass the ISO 13485 Foundation Exam to obtain ISO 13485 Foundation Certificate.

Who conducts ISO 13485 Foundation Exam in India?

Unichrone conducts ISO 13485 Foundation Exam at the end of the training course in the India.

Is ISO 13485 Foundation Exam an open book exam?

ISO 13485 Foundation Exam is an open book exam. Candidates can use reference materials while attempting ISO 13485 Foundation Exam.

How long is ISO 13485 Foundation Exam?

The ISO 13485 Foundation Exam is one hour long and consists of 30 multiple-choice questions.

What is the need for ISO 13485?

The ISO 13485 standard was launched by the international organization for standardization. This ISO standard specifies the requirements that have to be met by businesses that are involved in manufacturing medical devices. The quality of medical devices plays an important role in the health industry. As a result, organizations certified with ISO 13485 certification gain credibility and trust from stakeholders.

How can I get certified as ISO 13485 Foundation professional in India?

Individuals need to undergo ISO 13485 Foundation Training sessions. Thereafter, aspirants can clear the foundation exam and obtain the ISO 13485 Foundation Certification.

What is the benefit of ISO 13485 Foundation Certification in India?

The ISO 13485 Foundation Certification is internationally recognized. Aspirants can pursue their career options on a larger scale and earn higher salary packages. In addition, owning the certification helps aspirants to stand out from the crowd of regular professionals.

What are the prerequisites for pursuing ISO 13485 Foundation Certification in India?

Aspirants need not fulfill any prerequisites for pursuing ISO 13485 Foundation Certification in India.

What certification should I opt for after obtaining ISO 13485 Foundation Certification?

Candidates can go for ISO 13485 Lead Auditor Certification and ISO 13485 Lead Implementer Certification to broaden their knowledge of ISO 13485 standards.

Can ISO 13485 replace ISO 9001 standard?

ISO 13485 covers the ISO 9001 standard but with some additional features to fulfill the requirements of customers of Medical Device Quality Management organizations.

What is the difference between EN ISO 13485:2016 and ISO 13485:2016 standards?

ISO 13485 is an internationally recognized standard set of requirements to create a Medical Devices Quality Management System. However, EN ISO 13485 is a similar standard developed by the European Union for establishing MDQMS in the EU. It also offers various invaluable tables that align the ISO 13485:2016 standards with the EU medical device directives.

What is the validity of the ISO 13485 Foundation Certificate?

Candidates do not need to renew ISO 13485 Foundation Certificate, it is valid for a lifetime.

Will ISO 13485 Foundation Certificate help me to get a high salary?

Yes, ISO 13485 Foundation Certified professionals can earn an average salary of USD 80,000 per year according to payscale, which is high compared to non-certified professionals.

What can I do with ISO 13485 Foundation Certificate?

ISO 13485 Foundation Certificate holders can take job roles such as Quality Engineer, Quality Manager, Regulatory Affairs Specialist, Internal Auditor, Product Development Engineer, Quality Assurance Engineer, and Quality Assurance Director.

What is the ISO 13485 standard based on?

ISO 13485 is a stand-alone standard based on ISO 9001 quality management standard.

ISO 13485 Foundation Examination Procedure


Attend intense 1 day ISO 13485 Foundation Training offered by Unichrone. Fulfil all the requirements before the examination.


Apply for the Exam, conducted by Unichrone, whilst filling up all necessary details. Choose the suitable date for the exam.


Get certified after clearing the exam. You will receive an email confirming the status, after which you can check for certification.

What our customers say

Kenneth Beard

Project Manager

Very engaging course with real world context and wonderful examples. Helped to expand my knowledge as a direct result of it.

Tom Eeartman

Head-Supplier Management

Super awesome faculty! The best part of the training was lots of real time case studies and interactive sessions. Learnt many new concepts.

Pavit Kenth

Technical Director MCI Ltd

Interesting, Focused, Real life case studies. The material was a comprehensive presentation of Lean principles and Six Sigma.

Saad Alsheddi

Head Of Operations

Really interesting, a lot of knowledge about processes, in many areas and departments, helped to understand the subjects easily.

Jernej Hercog

Manager-Engineering Services

I opted for Instructor led Online Session. The training was very well executed. It was awesome and exceeded my expectations.

Register for a free session with our trainer

Select your city to view ISO 13485 Foundation Certification Training Course Schedule in India

Faculty and Mentors

Our certified and highly experienced trainers are handpicked from various industries to assist aspirants with practical insights into the field, thereby providing a comprehensive understanding of fundamentals and complex terminologies




Minimum Experience


Session Expertise

ISO 9001 standard emphasizes the enhancement of customer satisfaction for any organization irrespective of the industry it is operating in. On the contrary, ISO 13485 Standard is major based on increasing the quality of medical devices. This standard was published mainly to assist organizations involved in manufacturing medical devices and related services.

Professionals owning ISO 13485 Foundation Certification in India can take up the roles of quality engineer, product reviewer, quality managers, quality associates, and so on.

ISO 13485 Foundation Certified individuals are adept at making the most of data to reach effective solutions for improving processes. With their assistance, manufacturers are able to concentrate on the core areas of production.

Individuals with ISO 13485 Foundation Certification are sought after by organizations manufacturing or selling medical devices. They possess the expertise to ensure efficiency at all stages of quality assessment.

An individual with ISO 13485 Certification has the right to involve employees in sharing their thoughts regarding a procedure. He brings out the best ideas from the teams to rightly frame the task aimed at the device quality.

ISO 13485 Certification is awarded to organizations that manufacture medical devices and related services. Complying with this ISO standard ensures that the organization follows all the necessary protocols while manufacturing the medical equipment.

Professionals willing to earn the certification can enroll in ISO 13485 Foundation Training program offered by Unichrone. At the end of the session, individuals can attempt the exam and score 70% to earn the certification. The exact time period required to earn the certification cannot be determined. However, professionals who have sufficient knowledge of the standard and its requirements can easily earn ISO 13485 Certification in India.

With ISO 13485 Foundation Training, employees need not have to bother their managers for troubleshooting difficulties. Quick resolving of issues accelerates the production pace and keeps it error-free from the start.

ISO 13485 Foundation Training emphasizes data documentation and interpretation to improve the quality of operations. Well-defined procedures are maintained to help companies manufacture quality medical equipment.

An individual should undergo ISO 13485 Foundation Training in India for identifying defects. Training induces the urge to take corrective action without ignoring the flaws.


Amplify your value

ISO 13485 Foundation Certification is a recognized credential in various nations across the globe. This makes it easier for professionals owning ISO 13485 Foundation Certification in India to amplify their value in the organization.


Be compensated

ISO 13485 Foundation Certification is the entry-level credential offered to individuals pursuing a career in the medical device industry. As a result, certified ISO 13485 Foundation professionals in India can receive compensation higher than non-certified professionals.


Create your reputation

Professionals owning ISO 13485 Foundation Certification in India are distinguished from their non-certified counterparts. This permits certified ISO 13485 Foundation professionals to create their reputation and stand out from the crowd of regular professionals in the field.


Display your skills

ISO 13485 Foundation Certification is designed to offer practical knowledge of managing MDQMS. Professionals certified with ISO 13485 Foundation in India get to display their newly acquired skills in managing the quality of medical devices.

Our Clients

Importance of ISO 13485 Foundation Certification in India

Even the slightest tampering with a medical device can result in unexpected threats to human life. Apart from becoming a leading medical equipment brand, this concern drives the need to comply with ISO 13485. Proper governance is required to fulfill the criteria of this ISO certification for device selling, repairing, or manufacturing enterprises. Most eligible for this purpose are individuals possessing ISO 13485 Foundation Certification.

How Does One Benefit from ISO 13485 Foundation Training?

ISO 13485 Foundation Training in India is the stepping stone to attaining the certification. It is the primary phase followed by an exam. Undertaking this training is advantageous in multiple ways:

Healthcare Jobs

To be employed in the healthcare industry, one necessarily doesn’t have to be a doctor. Sectors related to the supply chain and production of medical instruments are equally important. These devices are integral parts of medical diagnosis. Through ISO 13485 Foundation Training, individuals gain precision in the fabrication of healthcare equipment. This broadens their scope of employment across these industries to explore diverse roles.

Quality Focus

ISO 13485 Foundation Training isn’t only centered around profit-making but human health. The concerned ISO principles comprising the quality benchmark for medical devices emphasize expertise in manufacturing and testing. Trained individuals are endowed with this expertise for which they are sought after by relevant organizations. They not only introduce measures but also spread awareness regarding the quality production of medical devices.

Brand Credibility

Trained individuals are adept at maintaining the reputation of medical instrument brands. They make the most of ISO 13485 directives by initiating organizational procedures accordingly. Their constant effort to improve production processes by eradicating flaws leads to the delivery of premium-grade products. More health-industry consumers start depending on such brands for their supplies.

Employee Education

Organizations entrust trained individuals with the task of supervising those directly executing the manufacturing operations. ISO 13485 Foundation Training imparts knowledge of the supply chain intricacies to identify the origin of flaws usually discovered in the course of production. This helps in teaching employees at all levels, to not ignore but resolve problems immediately and facilitate error-free manufacturing.

Improved Infrastructure

Other than technology, hygiene and calibration are primary factors when it comes to the manufacturing of medical equipment. Trained individuals are capable of enforcing a well-organized and ISO 13485 compliant infrastructure for medical instruments-making. They ensure that the directives of ISO 13485 are practically observed from device design to the final product.

Significance of ISO 13485 Foundation Certification

One has to score well in the exam to earn an ISO 13485 Foundation Certification in India. It is proof of a professional’s competencies in safely executing the production of medical devices. The certification is the door to multiple designations related to building, repairing, and trading in the medical device industries.

Professional Growth

Medical instrument suppliers/sellers need the approval of ISO 13485 to prove their genuineness globally. These enterprises hire certified individuals because they are the ones who align the operational procedures with the respective ISO guidelines. So, the demand for such talent is ever-increasing assuring a promising career for accredited professionals.

Risk Management

Professionals possessing ISO 13485 Foundation Certification are empowered to supervise risk management in device manufacturing. They have the potential of predicting possible dangers due to the use of substandard materials or inappropriate techniques. These professionals enforce only those measures that match the ISO standards. Thus, less wastage occurs and minimum harmful rubbish is released during the different production steps.

Spreading Awareness

ISO 13485 Foundation Certification enables one with the power of conducting training programs for the other management staff. Certified individuals spread the awareness of the consequences a medical equipment manufacturer can face for producing sub-standard products.

Management Review

Certified individuals are required for reviewing the management of an enterprise despite its support for implementing ISO 13485 rules. They examine the data concerning the outcomes of ongoing QMS practices. This is to ensure that proper resources are available for effective execution of those practices.

ISO 13485 Foundation Training is a learning phase by which individuals can contribute to the modern healthcare industry. The best part of this training is a consumer-oriented approach that gets instilled within aspirants. A successful medical device manufacturer/ supplier owes its credit to these trained individuals. The position and remuneration of these individuals can, thus, be well-imagined.

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