InstructorRoyed Training
TypeOnline Course
Price$550 USD / 25500 INR.
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online course in medical device regulation

Introduction

Course Type

Duration

Eligibility

Certification

Course Deliverable

Features

Related Courses

Medical Devices Regulatory Affairs course by royed

The Medical Device Regulation Course is to impart knowledge and practical understanding about the Regulation, Registration and approval process.

This online course utilizes interactive learning tools to guide each participant through the steps of medical devices regulation 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.

Course Code: RYD-006

Course Title: Post Graduate Certification Course in Medical Device Regulations (PGMDR)

Who should attend?

  • This course is ideal for Medical Devices Professionals who are seeking to improve their skills in the medical devices regulatory environment.
  • Those who are entering into regulatory affairs from other areas within a device company (Pharmacists, Clinical Trials, Marketing and others).
  • Anyone wishing to update their knowledge on registration in various across different regulatory bodies.
  • Those who are working in  Business Development and Strategic Planning department.

Our Registrants are in Takeda, Pfizer, Apolonia d.o.o., ITC-Pharma, GSK, Lipoxen (UK), Patheon, Mylan, Biocon, Micro Lab, GE Lifesciences, Orchid, Sanofi, AstraZeneca, Hospira, Ranbaxy, Julphar, Jhonson and Jhonson, Ethicon, Dr. Reddy’s Laboratory, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya Herbal Healthcare, Bangalore Pharmaceutical and Research laboratories, Sutures India, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Wintac Limited, Faveo Pharmaceuticals, Enzem, Leo Pharma, Accenture, Shaigan Pharmaceutical, Ceutica & Chemie, Medxplor Healthcare, Systopic Laboratories and many more companies across the pharma industry.

Online distance learning course. Course can be accessed online across anywhere 24×7.

1 Year from the date of initiation of the course.

Graduation in any discipline.

Certificate will be provided at the end of the successful completion of the course

  1. Attend the course 24×7 by login to your dashboard. You can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also be eligible to receive the course study modules, which you can download by login to your course page.
  • Advance understanding on medical device regulation across different regions, e.g. US, EU, Canada, GCC, ASEAN, LATAM, China, India etc.
  • Advance practical training in premarket approval process.
  • Advance training on technical dossier preparation.
  • Detailed training on ISO 13485 and CE certification process.
  • Training on Medical device technical dossier preparation.

Followings are the few of the similar courses, you may be interested in

Drug Regulatory Affairs Course >> Click here

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 50ISO 13485:2016 Audit Checklist
Section 13PRODUCT RECALL
Lecture 51Difference Between Product Recall & Market Withdrawal
Lecture 52Classification of Recall
Section 14Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Section 15Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 16Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt