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Standards, Certification and Accreditation

An industry-level course on Standards, Certification and Accreditation in the Biomedical Field.

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Syllabus

This course is full of best-in-class content by leading faculty and industry experts in the form of videos and projects

Course Overview

The students will gain a thorough knowledge of Standards, Certificates, and Accreditation
During the course work, the students will learn about
- Importance of compliance by way of explaining Standards (especially ISO 13485), Certification, Accreditation, international recognition, etc.
- Interpretation of Standards, effective implementation, and certification as well as ensuring global recognition.
- Certification Body (CB) and also to verify the authenticity of the product provided under the certified management system

Course Syllabus

On a daily basis we talk to companies in the likes of Tata Elxsi and Mahindra to fine tune our curriculum.

Standards - 1

Purpose of Standards and their benefits
Elements of Quality Infrastructure & Customer focus
Basic Structure of Standards
Types of Standards
National Standards Bodies and International Organization for Standardization (ISO)
Standards Development Process
Harmonization of Standards

Standards - 2

Applicable Standards for Medical Devices/Equipment
Brief Introduction to other Standards like
- IEC 60601-1
- ISO 16142-1
- ISO 16142-2
Key aspects of ISO 13485: 2016

Standards - 3

Key aspects of ISO 13485: 2016 - Implementation
- Quality Management Systems
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis, and Improvement

Certification - 1

Abbreviations and Definitions
What is Certification?
Why Certification?
Who provides Certification Services?
Selection of Certification Body
Certification Audit

Certification - 2

MS Certification Process
MS Certification maintenance process
MS Recertification process

Accrediation

Why accreditation?
Accreditation vs. Certification
Accreditation Standards
National Accreditation Framework - India
International Accreditation Framework
Global Acceptance Mechanism
Accreditation Process in brief
Accreditation Traceability

Our courses have been designed by industry experts to help students achieve their dream careers

Industry Projects

Our projects are designed by experts in the industry to reflect industry standards. By working through our projects, Learners will gain a practical understanding of what they will take on at a larger-scale in the industry. In total, there are 2 Projects that are available in this program.

Quality Evaluation

In this project, students must develop a detailed questionnaire to evaluate the quality of products and services provided by medical device manufacturing companies. This serves as a practice for the students to use such tools to develop a similar questionnaire for any area they may work in the future.

Risk Assessment

In this project, the students have to assume that they are working in a medical device manufacturing company and prepare a detailed risk assessment for the selected device to cover all important steps of the process (starting from design to delivery, to post-delivery services).

Our courses have been designed by industry experts to help students achieve their dream careers

Ratings & Reviews by Learners

Skill-Lync has received honest feedback from our learners around the globe.

4.8

Ensure the quality of critical medical devices as a testing engineer

According to Recruiter.com, the hiring of QA engineers is expected to increase by 2.32% yearly. It translates into 308,390 new jobs by 2029. Equipping yourself with the right skill set in standards certifications now, will help secure a lucrative career as a QA engineer.

Skill-Lync’s Standards, Certification and Accreditation is a 12-week online course. It will teach you the ISO standards to follow while manufacturing medical devices. An industry expert with 35 years of experience in quality management has carefully curated the course. As the curriculum strictly adheres to industry standards, it will help you become job-ready. Two industry-level projects are included in the curriculum to provide you with hands-on practice.

The advanced certification and accreditation process course will help you build the necessary skills to kickstart a career as a construction management engineer. The fee for learning the Standards, Certification and Accreditation course ranges from INR 7,000 to INR 15,000 monthly for three months.

Who Should Take This Course?

The industry-oriented accreditation certificate course is for engineering students and graduates interested in medical technology. If you are passionate about designing medical devices that can save human lives, this course is for you. Experienced professionals keen on expanding their skill sets can opt for this course.

What will you learn?

The course will teach you to inspect and test healthcare devices. The following concepts will be discussed in the course.

Elements of Quality Infrastructure & Customer focus
Applicable Standards for Medical Devices/Equipment
Key aspects of ISO 13485: 2016
Quality management system
Certification Audit
Accreditation Traceability

Skills You Will Gain

You will be able to check and determine the quality and reliability of a medical device.
Complete knowledge of standard industry practices.
In-depth knowledge of the National Accreditation Framework.

Key Highlights of The Program

Standards, Certification and Accreditation, is a 12-week-long course.
Besides the course completion certificate for all participants, the top 5% of learners get a merit certificate.
You will get email and forum support to clear your doubts during the course.
Real-time industry-relevant projects will make your learning purposeful and practice-oriented.

Career Opportunities After Taking The Course

Upon completing the Standards, Certification and Accreditation, numerous job opportunities will open up for you. Some challenging positions in the biomedical industry include

Quality Assurance Engineer
Quality Control Engineer
Quality Management Engineer
Inspection Engineer

FAQs on Standards, Certification and Accreditation Course

Who can take up the Standards, Certification and Accreditation course?

Engineering students and graduates who are ambitious and interested in developing devices to improve healthcare Standards, Certification and Accreditation courses.

Is Standards, Certification and Accreditation an online program?

Yes, the standards and certification course is 100% online.

What is the duration of the Standards, Certification and Accreditation course?

This advanced Standards, Certification and Accreditation is 12 weeks long, covering all the standards to be followed while manufacturing medical devices.

What is the fee for pursuing the Standards, Certification and Accreditation course?

The fee for learning Standards, Certification and Accreditation at Skill-Lync is flexible and is available in three plans. The basic plan provides you with two months of access at INR 7,000 per month, the Pro plan provides four months of access at INR 10,000 per month, and the Premium plan provides you lifetime access at INR 15,000 per month

How much can a medical device quality engineer earn?

According to Payscale, the average annual salary of a quality engineer is 4.2 LPA. However, your pay package varies with your experience and skills.

Is there any certificate for completing the Standards, Certification and Accreditation course?

Yes, you shall be given a course completion certificate after completing the Standards, Certification and Accreditation course. The top 5% of the scorers will receive a merit certificate alongside the course completion certificate.

Is any technical support available for this course?

Yes, you can clear your doubts during coursework from our technical support team through email and forum support.

Can you tell me more about Skill-Lync?

Skill-Lync is among India’s leading EdTech platforms dedicated to transforming engineering education. We equip young engineers with the latest skill sets and cutting-edge tools in new-age technologies.

The brainchild of two engineers from Chennai, Skill-Lync, is on a mission to bridge the skill gap between aspiring professionals and the industry’s demands through job-oriented courses.

Flexible Pricing

Talk to our career counsellors to get flexible payment options.

Premium

INR 40,000

Inclusive of all charges

Become job ready with our comprehensive industry focused curriculum for freshers & early career professionals

5 Years Accessto Skill-Lync’s Learning Management System (LMS)
Personalized Pageto showcase Projects & Certifications
Live Individual & Group Sessionsto resolve queries, Discuss Progress and Study Plans.
Personalized & Hands-OnSupport over Mail, Telephone for Query Resolution & Overall Learner Progress.
Job-Oriented Industry Relevant Curriculumavailable at your fingertips curated by Global Industry Experts along with Live Sessions.