InstructorRoyed Training
TypeOnline Course
Student Enrolled3
Price$650 USD / 32500 INR.
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medical device regulatory affairs

Introduction

Who should attend

Course Type

Duration

Eligibility

Certification

Course Deliverable

Features

Related Courses

medical devices regulatory affairs course

Medical Device Regulatory Affairs training Course is to impart practical knowledge about the Regulation and marketing authorization process. This PG certification course in Medical Devices also covers medical devices strategic management and planning process. Moreover, this course will demonstrate medical devices business skills  and concepts. Most importantly, The course provides cased based learning. As a result, it is easy for participants to understand the concepts. Above all, cutting edge simulations help participants apply the knowledge in interactive real life simulation. 

In addition, this medical devices regulatory affairs course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place. So, it allows the user to stop and start at their leisure. 

Moreover, user can access the course at own pace. Hence, it allows the user to stop and start at their leisure. 

Course Code: RYD-006

Course Title: Post Graduate Certification Course in Medical Device Regulatory Affairs (PGMDRA)

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.

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

1 Year from the date of initiation of the course. However, user can complete the course anytime within 1 year period. It means, if anyone want to complete within 3 or 4 month, he or she can do it effectively.

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. So, 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.

Course Features

This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of medical devices regulation and approval process in detail. Moreover, the course challenges 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.

Important Learning Features of Medical Devices Regulatory Affairs Course: 

  • Online 24×7 access from anywhere. Hence, one can learn at your convenience.
  • Hence, the course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
  • Interactive E-lectures helps user to understand of the concepts effectively.
  • Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.

Medical Devices Course Coverage Area

  • Advance understanding on medical device regulation across different regions, e.g. US, EU, Canada, GCC, ASEAN, LATAM, China, India etc.
  • Secondly, advanced practical training in premarket approval process cones handy to learner. In fact, it helps to inculcate the decision marking skill.
  • Also Detailed training on ISO 13485 and CE certification process is included in the course.
  • The course also provides hands on training Medical device technical dossier preparation.

Here you can find some medical device training courses for your reference.

Medical Devices Training Courses


Course Code
Course
Duration

RYD-083 (Executive Program)
Medical Device Global Business
1 Year

RYD-077
Drug Biologic Medical Device Regulatory Affairs
1 Year

RYD-006
Medical Devices Regulation
1 Year

RYD-082
US Medical Device Regulation
1 month

RYD-035
CE Certification in Medical Devices
3 Days
Section 1US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 1Overall Understanding of US Medical Devices
Lecture 2Definition of Medical Devices
Lecture 3Classification of Medical Devices
Lecture 4Medical Devices Classification : Work File 
Lecture 5Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Section 2510K PRE-MARKET NOTIFICATION
Lecture 6Overall Understanding
Lecture 7Predicate Devices | Substantially Equivalent (SE)
Lecture 8Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 9FDA decision making process for different classes of 510k applications
Lecture 10Review Test
Section 3PREMARKET APPROVAL (PMA) APPLICATION
Lecture 11Premarket approval (PMA) application
Lecture 12Differences between 510k VS. PMA
Lecture 13Data Requirements for A Premarket Approval (PMA) application
Lecture 14Data Requirements for A Premarket Approval (PMA) application
Lecture 15PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 16Labeling Requirement for Medical Devices
Lecture 17Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 18Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 19Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 20Expedited Review of PMA application
Lecture 21Expiration Dates
Lecture 22Device Master Files
Lecture 23Unapproved use of Medical Devices
Lecture 24Marketing, Advertising and Promotion of Medical Devices
Lecture 25Significance of Submitting a FDA 513(g)
Lecture 26DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 27Humanitarian Device Exemption (HDE)
Section 4COMBINATION PRODUCTS
Lecture 28Definition of combination products
Lecture 29Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 30Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Lecture 31Drug Led Combination Product Pathway - R&D Process & drug discovery pathway
Lecture 32Drug Led Combination Product Pathway - NDA
Lecture 33Drug Led Combination Product Pathway - ANDA
Lecture 34Drug Led Combination Product Pathway - BLA Submission
Lecture 35Drug Led Combination Product Pathway  -  Biosimilar Lead - 351(k)
Section 5Labeling Requirements for Medical Devices
Lecture 36Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 37Instruction for Use (IFU)
Lecture 38UDI | Different Component | How to design  
Section 6EU REGULATION FOR MEDICAL DEVICES
Lecture 39Medical Devices: EU Directives, Classification and Guidance, CE Marking.
Lecture 40Certification and Legal Requirements for Medical Devices | Conformity Assessment Planning
Section 7QMS, Documentation and Dossier Preparation
Lecture 41Medical Device Technical File
Lecture 42Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 43Quality Management System (QMS) for medical devices company 
Lecture 44Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 45Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 46Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 47Implant Card | Regulatory Importance | Content | How to design 
Section 8C-GMP REQUIREMENT FOR MEDICAL DEVICES
Lecture 48c-GMP Requirement for Medical Devices
Lecture 49GMP Exemptions
Lecture 50GMP - Premises & Plant Layout Designing
Lecture 51Sanitation and Hygiene
Lecture 52Equipment Modules
Lecture 53Production Modules
Lecture 54G5 Lecture Documentation
Lecture 55Quality Control
Lecture 56Product Complaint
Lecture 57Storage
Lecture 58Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 59Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 60Documentation | Good Documentation Practices
Lecture 61ISO and ISO Audits
Lecture 62Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Lecture 63Certification and Legal Requirements for Medical Devices | Conformity Assessment Planning
Section 9MEDICAL DEVICES REGULATION IN INDIA
Lecture 64Medical Devices Regulation in India | Overall understanding
Lecture 65Regulatory Landscape in India
Lecture 66Classification of the Medical Devices in India | Strategic Planning for the Submission 
Lecture 67Notified and Non-notified Device | Submission Strategic Planning 
Lecture 68Medical Devices Classification in India - Work Doc
Lecture 69Notified Devices | Registration Process
Lecture 70Medical Device Submission Strategic Pathways | Step by step Process 
Lecture 71Medical Device Forms | Purposes
Lecture 72Non Regulatory Medical Devices
Lecture 73Medical Device Voluntary Registration | Documentation | Process
Lecture 74List of Notified Devices | Newly Notified Devices | Significance
Lecture 75List of Notified Bodies with CDSCO
Section 10CE MARKING
Lecture 76Introduction to CE Marking
Lecture 77CE- Self Certification
Lecture 78General principles of the CE marking
Lecture 79Manufacturer Responsibilities
Lecture 80Third Party Medical Device Manufacturing & CE Marking
Lecture 81Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 82Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 83Step By Step CE Marking Process
Lecture 84Case Study
Section 11TECHNICAL DOSSIER
Lecture 85Introduction
Lecture 86Components of technical documentations
Lecture 87Technical Dossier - Information Required
Section 12ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 88Introduction to ISO 13485:2016
Lecture 89ISO 13485:2016 Audit Checklist
Section 13Medical 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 14Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 15Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Section 16Medical Devices Regulation in Canada
Section 17Final Examination and Certificate Generation
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