ISO 13485 Foundation Training

As per International Standards

  • Online/Group Sessions
  • 1 Day
  • Examination Included
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Boost your Medical Device expertise with ISO 13485 Foundation Certificate

ISO 13485 is an international standard for Medical Device Quality Management System. It is a framework for designing, developing, manufacturing, installing, and maintaining medical equipment. The standard guarantees the safety and effectiveness of medical devices manufactured. In several countries, having ISO 13485 Certification is a requirement for entry into the marketplace. So, businesses manufacturing medical devices need experts who are familiar with the requirements. ISO 13485 Foundation Certified professionals to assist in complying with the ISO 13485 Standard. This further boosts their credibility in the market thereby enhancing their competence.

ISO 13485 Foundation Certification Training

ISO 13485 Foundation Certificate validates professionals’ mastery of ISO 13485 and its requirements. The certificate enhances their career prospects within the medical device industry. It shows an individual's dedication to quality management and regulatory compliance. Individuals can enroll in ISO 13485 Foundation Training to know the basics of ISO 13485 and its relevance to medical devices. The course further focuses on MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review, and continuous improvement.

Key Features of ISO 13485 Training

ISO 13485 Foundation Training is suitable for individuals who manage MDQMS. Participants learn about the scope of the standard and its key concepts. Unichrone lets applicants select their preferred training method. The program is organized in live online instructor-led or in-classroom method. ISO 13485 Foundation Course prepares candidates to apply best practices followed in the field. Our qualified trainers use real-world situations to provide trainees with hands-on experience. This makes it easier for professionals to comprehend the ISO 13485 Standard comprehensively. Candidates need to pass the ISO 13485 Foundation Exam after completing their course. Clearing the exam entitles individuals to receive the ISO 13485 Foundation Certificate. Owning the credential proves their proficiency in the ISO 13485 standard which gives them an edge in ISO 13485 Foundation Interview.

  • 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
Total Questions 30 Questions
Passing Score 70% passing marks
Exam Duration 1 hour

ISO 13485 Foundation Training Course Curriculum

ISO 13485 Foundation Certification Benefits

Higher Salary

Earn 20% more salary than non-certified professionals in the field

Greater Responsibilities

Enhance your performance with additional responsibilities in the organization

Diverse Job Roles

Broaden your scope at the organization as compared to your peers

Global Recognition

Global recognition across different domains and industries with this certificate

Versatile Opportunities

Land at your dream job in large organizations with great expertise

Sophisticated Skillsets

Validates the advanced experience, skills and knowledge gained by professionals

Frequently Asked Questions

Why should I take up ISO 13485 Foundation Training?

Enrolling in ISO 13485 Foundation Training course enables individuals to acquire a deeper understanding of the standard. During the course, our highly qualified trainers engage in conducting practical exercises. This further helps candidates to grasp the complex terminologies of the standard and clear the exam in the first attempt.

What is provided during the course if ISO 13485 Foundation Training?

During ISO 13485 Foundation course, candidates can access extensive training material, case studies, and mock tests.

Can I take up online ISO 13485 Foundation Certification Training?

Yes, at Unichrone we offer live online instructor-led sessions and in-classroom sessions. Candidates can choose their desired mode of ISO 13485 Foundation Training while enrolling in the course.

How long is the ISO 13485 Foundation Course?

The ISO 13485 Foundation Training is conducted for a day across various nations.

How is ISO 13485 Foundation Exam conducted?

The ISO 13485 Foundation Exam is required to attempt 30 multiple choice questions within 1 hour. Professionals who clear the exam are awarded ISO 13485 Foundation Certification.

Who offers the ISO 13485 Foundation Exam?

The ISO 13485 Foundation Exam is governed Unichrone which is globally recognized.

What is the passing score to clear ISO 13485 Foundation Exam?

Candidates need to obtain 70% or more to clear ISO 13485 Foundation Exam.

What is ISO 13485?

ISO 13485:2016 Standard specifies the requirements for maintaining the quality of medical devices and related services. ISO 13485 is the international standard established for managing the quality management system. Organizations that need to be certified under this standard need to demonstrate their ability in manufacturing medical devices. These medical devices are manufactured in accordance with the standard.

How does an organization benefit from ISO 13485?

An organization that is certified with ISO 13485 standard gains recognition and access to markets worldwide. Organizations holding the certification of ISO 13485 showcase that their medical devices are safer and in accordance with the quality standard. In addition, certified organizations can increase the efficiency of the process involved in manufacturing medical devices.

Why should individuals pursue ISO 13485 Foundation Certification?

Professionals certified with ISO 13485 Foundation Certification stand out from the crowd of regular professionals. Such professionals possess basic knowledge of the standard and its requirements. Organizations hire such professionals to assist them in implementing the standard within the structure. Recruiting certified professionals gains the trust of customers looking for standardized medical devices and related services.

Is there any prerequisite to take up ISO 13485 Certification?

No, there are no prerequisites for pursuing ISO 13485 Foundation Certification. Individuals who have an interest in pursuing a career in this field can enroll for the course and pursue the certification.

What is ISO 13485 audit management?

Businesses must thoroughly audit all applicable standards for a medical device to ensure compliance with product safety and efficacy. The ISO 13485 audit offers an unbiased evaluation of the companies' operational and legal conformity with the most recent ISO 13485:2016 standard.

Will ISO 13485 improve business reputation?

ISO 13485 is widely regarded as a symbol of a trustworthy business and high-quality products. Therefore, it improves the company's reputation with existing and future clients, investors, partners, suppliers, and other stakeholders.

Is training necessary for employees during ISO 13485 implementation?

Yes, ISO 13485 Training is necessary for all employees. Organizations should ensure that every employee is informed of the organization's plans to implement ISO 13485. They also should be informed about how implementation will affect them, their duties, and how implementation will benefit them.

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. Attend the exam scheduled at the end of the training session.


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

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

The ISO 13485 Foundation exam fee is included in the training cost offered by Unichrone.

Yes, candidates can retake the exam free for the second time. Subsequent attempts after 2nd attempt, the re-examination fees to be paid.

The market time for devices is shortened by MDQMS, which also improves supplier management and flexibility in accordance with industry norms. It provides a thorough root cause assessment in the event of a mistake and eliminates non-value-added and wasteful operations.

ISO 13485 is a voluntary standard. Having a certificate shows stakeholders and business partners that a company has made every attempt to comply with the standard.

The International Standards Organization created the ISO 13485 standard to provide medical device firms with guidelines for building and maintaining quality systems.

The ISO 13485 certification serve as proof of Quality Management System compliance with the standard for organizations involved in the Medical Device industry.

The first edition of ISO 13485 was released in 1996, and revisions followed in 2003 and 2016. The most recent version, ISO 13485:2016, came into effect in March 2016.

Professionals can pursue higher prospects in an organization that develops medical devices. In addition, professionals can broaden their knowledge on ISO 13485 standards by enrolling in ISO 13485 Lead Auditor Certification and ISO 13485 Lead Implementer Certification.

Individuals willing to pursue ISO 13485 Foundation Certification need to undertake the ISO 13485 Training course offered by Unichrone. Thereafter, candidates can take up the exam and clear it in the first attempt to acquire the ISO 13485 Foundation Certification.

The ISO 13485 standard has eight clauses, with the first three serving as introductions and the latter five containing the mandatory requirements for the MDQMS.

Organizations can develop a quality management system with the aid of the ISO 9001 and ISO 13485 standards. Both standards prioritize risk assessment and minimization. They both put an emphasis on understanding the customer to provide quality products, as well as expertise and infrastructure for quality.

As per ISO 13485, organizations should monitor and measure product performance by
  • Managing complaints
  • Making appropriate notifications and reports to regulatory authorities
  • Identifying and addressing any non-conforming products
  • Continually monitoring product performance and working to improve processes

The cost of ISO 13485 certification might differ from one business to another. The cost is determined by company size, risk factors, complexity of the management system, and number of shifts.

ISO 13485:2016 Standard, Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and FDA 21 CFR Part 820 Regulation are some of the international standards and regulations governing medical device quality management systems.


Interpret the skills

ISO 13485 Foundation Certification is one of the internationally recognized certifications in the medical device industry. Professionals taking up ISO 13485 Foundation Certification can easily interpret their skills and conform to the requirements of the ISO standard.


Establish your career

In recent years, ISO 13485 Foundation Certification has gained immense popularity. Professionals interested in broadening their knowledge of the ISO 13485 standard get to establish their careers in the medical device industry with the Foundation Certification.


Be chosen

ISO 13485 Foundation Certification holders stand out from regular professionals in the field. This makes it easier for certified ISO 13485 Foundation professionals to get identified and recruited by large organizations in the medical device industry.


Impress your peers

Certified ISO 13485 Foundation professionals are offered higher salary packages when compared to their counterparts in the field. This further enables certified individuals to impress senior professionals and peers through advanced knowledge.

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