TypeOnline Course
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Price$330 / Rs. 16500
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Course Code: KPE-C-018

Course Title: KPE’s Certificate Course in Medical Device Regulations.

Course Objective: The objective of this course is to impart knowledge and practical understanding about the Medical Devices types, regulatory overview and approval process of Medical Devices.

This online course utilizes interactive learning tools to guide each participant through the steps of medical devices regulations and approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a medical devices company (Pharmacists, Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on Medical devices industry
  • Anyone who want to know / update about the Medical Devices Business Management / Strategic Planning

1. Orientation to practical understanding Medical Devices classifications and understanding of the regulatory approval process.

2. Simulation to real life Strategic planning in medical devices management – premarket and post market.

3. Access to industry case studies.

4. Attend Live Lectures of all different chapters / study content.

1 Month 

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to know or upgrade their knowledge about medical devices regulation, can pursue the course.

Rs. 16,500/- Indian Rupees (Payment from India)

330 USD (Payment from outside India)

This course is divided into following modules

1. Overview of medical devices – Introduction, Classifications and Designs.

2. Understanding of the different classes of medical devices in detail.

3. Practical knowledge of medical devices approval process (Pre market requirement)

4. Detailed understanding of the Quality Documentation

5. Handling of the Product Complaint & Product Recall.

6. Handling of Product Withdrawal from market.

7. Marketing, Advertising, Promotion of the medical devices

8. Strategic Business Model for the medical devices companies.

Course Flow:

Phase 1: US Medical Devices

Section 1

Content

US Medical Devies Market – Introduction & SWOT  Analysis

Definition of Medical Devices

Different Classes of Medical Devices and their working principal

USFDA – Classification for Medical Devices based on risk

USFDA – CDRH Overview

Medical Devices Regulation in US Introduction to Medical Devices

Section 2

Content

USFDA regulation

510(k) pre-market notification

Pre-market approval

Section 3

Content

Details understanding of Pre Market Approval Process with flow chart

510k VS. PMA

Investigational Device Exemption

Section 4

De Novo Petition – Medical Devices Regulation

Section 5

Investigational Device Exemption (IDE)

Device Clinical Research

Early/Expanded Access of Medical Devices

Trials of Medical Devices

Humanitarian Device Exemption (HDE)

Section 6: Labeling Requirement for Medical Devices

Section 7: Marketing, Advertising and Promotion of Medical Devices

Section 8: Unapproved use of Medical Devices

Phase 2 : Review Assessment Tests on USFDA Medical Devices

Phase 3: EU Regulations

Section 1 : EU regulation of Medical Devices Session 1  

Medical Devices: EU Directives, Classification and Guidance, CE Marking.

Section 2: Quality Management System (QMS) for medical devices company

ISO Certification for Medical Devices company

CE Marking for Medical Devices company

Medical Device regulatory professionals responsibility

Phase 4: c-GMP Requirement for Medical Devices

Phase 5: Medical Devices Regulation in India

Phase 6: Medical Devices Regulation Review – Canada, United States, Europe and Australia

Phase 7: Medical Devices Classification from different regulatory bodies perspective

Phase 8: Packaging standard for Medical Devices

Phase 9: Medical device safety and risk management

Phase 10: Effectiveness/performance of medical devices

Phase 11: Medical Devices Life Cycle Management

Phase 12: Standard of Medical Devices

Phase 13: Case Study on Medical Devices

Section 1US Medical Devices
Lecture 1Overall Understanding of US Medical Devices
Lecture 2Definition of Medical Devices
Lecture 3Classification of Medical Devices
Lecture 4Examples of Medical Devices
Lecture 5Review Test
Section 2510k Pre-market Notification
Lecture 6Overall Understanding
Lecture 7Types of 510(k)s
Lecture 8FDA 510(k) Step By Step - Decision Making process
Lecture 9FDA decision making process for different classes of 510k applications
Lecture 10Review Test
Section 3Premarket approval (PMA) application
Lecture 11What is Premarket approval (PMA) application?
Lecture 12Differences between 510k VS. PMA
Lecture 13PMA - for unclassified device?
Lecture 14Data Requirements for A Premarket Approval (PMA) application
Lecture 15PMA - Quality System
Lecture 16Labeling Requirements
Lecture 17Investigational Device Exemption
Lecture 18PMA Postapproval Requirements
Lecture 19Postmarket Surveillance Studies
Lecture 20PMA Supplements and Amendments
Lecture 21Expedited Review of PMA application
Lecture 22Expiration Dates
Lecture 23Device Master Files
Lecture 24Unapproved use of Medical Devices 
Lecture 25Marketing, Advertising and Promotion of Medical Devices
Lecture 26Significance of Submitting a FDA 513(g)
Lecture 27De Novo Petition
Lecture 28Humanitarian Device Exemption (HDE)
Section 4Combination Products
Lecture 29Definition of combination products
Lecture 30Examples of Combination Products
Lecture 31Premarket Review and Postmarket Regulation of Combination Products
Section 5Medical Devices Regulation in Canada
Section 6EU Regulation for medical devices
Section 7QMS for Medical Devices
Section 8c-GMP Requirement for Medical Devices
Section 9Medical Devices Regulation in India
Section 10CE Marking
Lecture 37Introduction to CE Marking
Lecture 38CE- Self Certification
Lecture 39General principles of the CE marking
Lecture 40Manufacturer Responsibilities
Lecture 41Third Party Medical Device Manufacturing & CE Marking
Lecture 42Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 43Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 44Step By Step CE Marking Process
Lecture 45Case Study
Section 11Technical Dossier
Lecture 46Introduction
Lecture 47Components of technical documentations
Lecture 48Technical Dossier - Information Required
Section 12ISO 13485:2016 : Implementation in Medical Device Organization
Lecture 49Introduction to ISO 13485:2016
Lecture 50 ISO 13485:2016 Audit Checklist
Section 13Product Recall
Lecture 51Difference Between Product Recall & Market Withdrawal
Lecture 52Classification of Recall