Get an in-depth understanding of regulatory processes for medical devices.
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This course is full of best-in-class content by leading faculty and industry experts in the form of videos and projects
On a daily basis we talk to companies in the likes of Tata Elxsi and Mahindra to fine tune our curriculum.
Module 1 - Overview of Indian MDR2017 Part I
Module 2 - Overview of Indian MDR2017 Part II
Module 3 - Schedules of MDR - Part 1
Module 4 - Schedules of MDR - Part 2
Module 5 - Schedule - CE Marking
Module 6 - Overview of the Two Important Global Regulations - EU MDR and US FDA
Module 7 - Indian MDR,2017 vs EU regulations (MDR-2017/745 & IVDR-2017/746)
Module 8 - Other Countries Regulation which Interlinked with Indian Medical Device Rules
Module 9 - Standards - 1
Module 10 - Standards - 2
Module 11 - Standards - 3
Module 12 - Certification - 1
Module 13 - Certification - 2
Module 14 - Accreditation
Our courses have been designed by industry experts to help students achieve their dream careers
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.
Preparation of a Dummy Design Docket by Schedule V of the MDR URS
In this project, students will have to prepare a dummy design docket as required by schedule V of the MDR URS.
Students will be asked to do the following:
Clinical Investigation Plan
This project deals with the clinical investigation plan's identification, overall synopsis, and justification.
In this project, students will be asked to
Our courses have been designed by industry experts to help students achieve their dream careers
Skill-Lync has received honest feedback from our learners around the globe.
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.
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.
14 years in the experience range
Instructors with 14 years extensive industry experience.
Areas of expertise
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