Standards, Certification and Accreditation
An industry-level course on Standards, Certification and Accreditation in the Biomedical Field.
RELATED RECENT PLACEMENTS
Parthiban M
Riverstone
SRM TRP Engineering College
Kotesh Mogudala
Tata Autocomp Systems
Anurag University, Hyderabad
Vipin Jiwane
Orena Solutions
Walchand College of Engineering, Sangli
Chandrakumar ADEPU
Selec Control
Ganapathy Engineering College
Jiji M
Adrasti
Sreepathy Institute of Management And Technology (SIMAT)
Durga Prasad Sunnam
Adrasti
Ucet Technical school in Dokiparru, Andhra Pradesh
Pratik Mankar
Adrasti
B R Harne College Of Engineering
MAHATHIR MOHAMED
TATsunoInida Pvt ltd
K.S.K College of Engineering and Technology
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.
Flexible Pricing
Talk to our career counsellors to get flexible payment options.
INR 40,000
Inclusive of all charges
Become job ready with our comprehensive industry focused curriculum for freshers & early career professionals
1 Year 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.
Instructors profiles
Our courses are designed by leading academicians and experienced industry professionals.
1 industry expert
Our instructors are industry experts along with a passion to teach.
35 years in the experience range
Instructors with 35 years extensive industry experience.
Areas of expertise
- Quality Management
- Management Systems
Similar Courses
Got more questions?
Talk to our Team Directly
Please fill in your number & an expert from our team will call you shortly.