Executive Programs

Workshops

Projects

Blogs

Careers

Student Reviews

For Business

Academic Training

Informative Articles

Find Jobs

We are Hiring!

All Courses

Choose a category

All Courses

Regulatory processes for medical devices

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

RELATED RECENT PLACEMENTS

Bhavesh Kumbhare

Dar Al-Handasah Engineering company

Rashtrasant Tukadoji Maharaj Nagpur University

Akash Bhadkumbe

XS CAD

Brahmdevdada Mane Polytechnic

Madhura Joshi

NEILSOFT LIMITED

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

& 1200+ more

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 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