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 …
Biomedical · Course
Standards, Certification and Accreditation
An industry-level course on Standards, Certification and Accreditation in the Biomedical Field.
- Duration
- 12 weeks
- Content
- 10 hours
- Projects
- 2
- Mode
- Online
OverviewWhat you'll
What you'll
be able to do.
- 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
Curriculum6 modules,
6 modules,
built with industry.
01Standards, Certification and Accreditation
- Standards - 1W01
- 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 - 2W02
- 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 - 3W03
- Key aspects of ISO 13485: 2016 - Implementation
- Quality Management Systems
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis, and Improvement
- Key aspects of ISO 13485: 2016 - Implementation
- Certification - 1W04
- Abbreviations and Definitions
- What is Certification?
- Why Certification?
- Who provides Certification Services?
- Selection of Certification Body
- Certification Audit
- Certification - 2W05
- MS Certification Process
- MS Certification maintenance process
- MS Recertification process
- AccrediationW06
- Why accreditation?
- Accreditation vs. Certification
- Accreditation Standards
- National Accreditation Framework - India
- International Accreditation Framework
- Global Acceptance Mechanism
- Accreditation Process in brief
- Accreditation Traceability
- Standards - 1W01
Industry projects2 projects
2 projects
you'll ship.
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.
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…
FeeOne fee.
One fee.
Everything included.
Become job ready with our comprehensive industry focused curriculum for freshers & early career professionals
Premium
₹40,000
Inclusive of all charges- 1 Year Access
- Personalized Page
- Live Individual & Group Sessions
- Personalized & Hands-On
- Job-Oriented Industry Relevant Curriculum
FAQQuestions,
Questions,
answered.
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.
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Next stepNot sure it's
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the right fit?
A counsellor will walk you through the syllabus, projects and fee options — and tell you honestly if another course suits you better.