InstructorRoyed Training
TypeOnline Course
Student Enrolled9
Price$690 USD / 34500 INR.
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medical device regulatory affairs course

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
Lecture 6How to establish the classification of the medical device 
Lecture 7FDA Product Code Database : Hands on Training
Lecture 8513(g) Application : Request, User Fees, Review Process
Section 2510K PRE-MARKET NOTIFICATION
Lecture 9Overall Understanding
Lecture 10Predicate Devices | Substantially Equivalent (SE)
Lecture 11Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 12FDA decision making process for different classes of 510k applications
Lecture 13Review Test
Section 3PREMARKET APPROVAL (PMA) APPLICATION
Lecture 14Premarket approval (PMA) application
Lecture 15Differences between 510k VS. PMA
Lecture 16Data Requirements for A Premarket Approval (PMA) application
Lecture 17Data Requirements for A Premarket Approval (PMA) application
Lecture 18PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 19Labeling Requirement for Medical Devices
Lecture 20Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 21Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 22Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 23Expedited Review of PMA application
Lecture 24Expiration Dates
Lecture 25Device Master Files
Lecture 26Unapproved use of Medical Devices
Lecture 27Marketing, Advertising and Promotion of Medical Devices
Lecture 28Significance of Submitting a FDA 513(g)
Lecture 29DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 30Humanitarian Device Exemption (HDE)
Section 4COMBINATION PRODUCTS
Lecture 31Definition of combination products
Lecture 32Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 33Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Lecture 34Drug Led Combination Product Pathway - R&D Process & drug discovery pathway
Lecture 35Drug Led Combination Product Pathway - NDA
Lecture 36Drug Led Combination Product Pathway - ANDA
Lecture 37Drug Led Combination Product Pathway - BLA Submission
Lecture 38Drug Led Combination Product Pathway  -  Biosimilar Lead - 351(k)
Section 5Labeling Requirements for Medical Devices
Lecture 39Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 40Instruction for Use (IFU)
Lecture 41UDI | Different Component | How to design  
Section 6EU REGULATION FOR MEDICAL DEVICES
Lecture 42EU MDR Classification
Lecture 43EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 44EU MDR  | Annexes | Key notes
Lecture 45EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 46EU MDR Guideline | EU MDR - Annexes 
Lecture 47EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 48EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 49EU MDR Compliance Process 
Lecture 50Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices 
Lecture 51Review: DDF DHF DMR MDF DHR
Section 7QMS, Documentation and Dossier Preparation
Lecture 52Medical Device Technical File
Lecture 53Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 54Quality Management System (QMS) for medical devices company 
Lecture 55Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 56Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 57Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 58Implant Card | Regulatory Importance | Content | How to design 
Section 8C-GMP REQUIREMENT FOR MEDICAL DEVICES
Lecture 59c-GMP Requirement for Medical Devices
Lecture 60GMP Exemptions
Lecture 61GMP - Premises & Plant Layout Designing
Lecture 62Sanitation and Hygiene
Lecture 63Equipment Modules
Lecture 64Production Modules
Lecture 65G5 Lecture Documentation
Lecture 66Quality Control
Lecture 67Product Complaint
Lecture 68Storage
Lecture 69Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 70Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 71Documentation | Good Documentation Practices
Lecture 72ISO and ISO Audits
Lecture 73Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Lecture 74Certification and Legal Requirements for Medical Devices | Conformity Assessment Planning
Section 9MEDICAL DEVICES REGULATION IN INDIA
Lecture 75Medical Devices Regulation in India | Overall understanding
Lecture 76Regulatory Landscape in India
Lecture 77Classification of the Medical Devices in India | Strategic Planning for the Submission 
Lecture 78Notified and Non-notified Device | Submission Strategic Planning 
Lecture 79Medical Devices Classification in India - Work Doc
Lecture 80Notified Devices | Registration Process
Lecture 81Medical Device Submission Strategic Pathways | Step by step Process 
Lecture 82Medical Device Forms | Purposes
Lecture 83Non Regulatory Medical Devices
Lecture 84Medical Device Voluntary Registration | Documentation | Process
Lecture 85List of Notified Devices | Newly Notified Devices | Significance
Lecture 86List of Notified Bodies with CDSCO
Section 10CE MARKING
Lecture 87Introduction to CE Marking
Lecture 88CE- Self Certification
Lecture 89General principles of the CE marking
Lecture 90Manufacturer Responsibilities
Lecture 91Third Party Medical Device Manufacturing & CE Marking
Lecture 92Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 93Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 94Step By Step CE Marking Process
Lecture 95Case Study
Section 11ISO requirements for medical device industry
Lecture 96Introduction to ISO 13485:2016
Lecture 97ISO 13485:2016 Audit Checklist
Lecture 98ISO 10993 | Importance | Guidelines | Roadmap for ISO 10993 | Biological Evaluation Plan (BEP) | Differences between ISO 13485 and ISO 10993 | ISO 10993 Checklist
Section 12Medical 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 13Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 14Medical Devices Regulation in Africa
Lecture 101South Africa Medical Device Regulation
Lecture 102Egypt Medical Device Regulation
Lecture 103Kenya Medical Device Regulation
Lecture 104Nigeria Medical Device Regulation
Section 15Medical Devices Regulation in Canada
Section 16MDSAP Training
Lecture 106Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 107QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences 
Lecture 108MDSAP Stakeholders 
Lecture 109MDSAP Process Structure Audit Task
Lecture 110MDSAP Document Preparation
Section 17Final Examination