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Regulatory processes for medical devices

Get an in-depth understanding of regulatory processes for medical devices.

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Bhavesh Kumbhare

Dar Al-Handasah Engineering company

Rashtrasant Tukadoji Maharaj Nagpur University

Akash Bhadkumbe


Brahmdevdada Mane Polytechnic

Madhura Joshi


Government Polytechnic Ratnagiri

Surbhi Kadayalwar

Aarvee Consultants

Priyadarshini College of Engineering

Dhananjay Shinde

Hyundai Motor India Ltd

Government Engineering college and reseacrch

Karan Dilip Pawar

Oktal Sydac

father agnel polytechnic vashi

Sumedh Lokhande

Mazameer Design & Engineering Studio

Shri Datta Meghe Polytechnic

Rajashree Kadam

Hinduja Tech

Gokhale Education Society's R. H. Sapat College of Engineering, Management Studies and Research


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 on
    • Medical device classification, registration, licensing, and timelines
    • Approvals from central or state authorities for product release
    • Filling an application for a medical device product launch
  • The course also details the process of medical device registration, approvals, fees, and timelines for all processes that are required for medical devices or in-vitro diagnostic devices manufacturing, distribution, or importing.

Course Syllabus

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

  • Introduction
  • Preliminary
  • Regulation of Medical Device
  • Authorities, Officers, and Bodies
  • Manufacture of Medical Devices for Sale and Distribution
  • Import of Medical Devices
  • Labeling of Medical Devices

Module 2 - Overview of Indian MDR2017 Part II

  • Clinical Investigation of Medical Devices and Clinical Performance Evaluation of New In Vitro Diagnostic Medical Devices
  • Import or Manufacture a Medical Device that does not Have a Predicate Device
  • Duties of Medical Device Officer, Medical Device Testing Officer, and Notified Bodies
  • Registration of Laboratory for Carrying out Test or Evaluation
  • Sale of Medical Devices

Module 3 - Schedules of MDR - Part 1

  • First Schedule - Parameters for Classification of
    • Medical Devices
    • In Vitro Diagnostic Medical Devices
  • Second Schedule - Fee Payable for License, Permission, and Registration Certificate
  • Third Schedule - Documents Required for Registration of Notified Body, its Duties, and Functions.

Module 4 - Schedules of MDR - Part 2

  • Fourth Schedule
    • Documents required for Grant of License to Manufacture for Sale or for Distribution or Import

Module 5 - Schedule - CE Marking

  • Fifth Schedule
    • Quality Management System for Medical Devices
    • In vitro Diagnostic Medical Devices

Module 6 - Overview of the Two Important Global Regulations - EU MDR and US FDA

  • Sixth Schedule - Post Approval Change
  • Seventh Schedule - Requirements for permission to import or manufacture an investigational medical device for conducting a clinical investigation
  • Eighth Schedule - Exemptions

Module 7 - Indian MDR,2017 vs EU regulations (MDR-2017/745 & IVDR-2017/746)

  • Introduction about EU MDR-2017/745 & IVDR - 2017/746
  • How Indian Medical Device Rules, 2017 will Interlink with MDR - 2017/745 & IVDR - 2017/746

Module 8 - Other Countries Regulation which Interlinked with Indian Medical Device Rules

  • WHO-PQ (Prequalification)
  • US-FDA
  • TGA Medical Device Regulations

Module 9 - 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

Module 10 - 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

Module 11 - Standards - 3

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

Module 12 - Certification - 1

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

Module 13 - Certification - 2

  • MS Certification Process
  • MS Certification Maintenance Process
  • MS Recertification Process

Module 14 - Accreditation

  • 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.

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:

  • Deliver the learning of regulatory policies requiring information about the device master file.
  • Understand the requirements of market clearance of devices in the Indian market.
  • Provide requirements on product description including risk analysis related to design and manufacturing processes.
  • Provide characteristics of verification and validation – Analytical and clinical performance reports.

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 

  • Deliver the learning of policies involved in the clinical investigation plan, its justification, and conducting the investigation.
  • Visualize and frame the risks and benefits of the investigational medical device and clinical investigation of its objectives and hypotheses.
  • Design statistical considerations data management relevant to clinical investigation

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.

Google Rating

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.


14 years in the experience range

Instructors with 14 years extensive industry experience.


Areas of expertise

  • Medical device

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