InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 18500 INR.
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US medical device regulatory affairs

Introduction

Who should attend

Course Type

Duration

Eligibility

Certification

Course Deliverable

Features

Related Courses

us medical devices regulation training

The US Medical Device Regulation Course is to impart knowledge and practical understanding about the Regulation, Registration and approval process in United States. This advanced certification course in Medical Devices also covers medical devices strategic management and planning process. Hence, this course will demonstrate medical devices business skills  and concepts. The course provides cased based learning. As a result, it is easy for participants to understand the concepts. Moreover, cutting edge simulations help participants apply the knowledge in interactive real life simulation.US medical devices regulation

Therefore, US medical device training course provides provide medical devices submission process for US market. Also at the same time, course provided advanced insight on various pathways for USFDA medical devices approval.   

In addition, this 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. It allows the user to stop and start at their leisure. 

Course Code: RYD-082

Course Title: Advanced Certification in US Medical Devices Regulatory Affairs (ACUSMDR)

Who should attend?

  • This course is ideal for US Medical Devices Professionals.
  • In fact, the course suits to those who are seeking to improve their skills in the US medical device 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.
  • Most importantly, this course suits to medical devices regulatory professionals who are handling US market.

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

1 month 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.

Course Features

This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of US medical device regulation and approval process in detail. 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: 

  • Online 24×7 access from anywhere. Hence, one can learn at your convenience.
  • 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.

Course Coverage Area

  • The course provided comprehensive advanced understanding on US medical device regulation.
  • 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.

Related Courses

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

  • Drug Regulatory Affairs Course >> Click here
  • Online Training on CE certification >> Click here
  • Medical devices regulatory affairs >> Click here
  • Drug, Biologic and Medical Devices Regulatory Affairs Course >> Click here
  • USFDA Pharmaceutical and Biopharmaceutical Regulatory Affairs >> 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 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 29Examples of Combination Products
Lecture 30Premarket Review and Postmarket Regulation of Combination Products
Section 5QMS FOR MEDICAL DEVICES
Section 6C-GMP REQUIREMENT FOR MEDICAL DEVICES
Lecture 32c-GMP Requirement for Medical Devices
Lecture 33Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 34Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 35Documentation | Good Documentation Practices
Lecture 36Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Section 7CE 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 8TECHNICAL DOSSIER
Lecture 46Introduction
Lecture 47Components of technical documentations
Lecture 48Technical Dossier - Information Required
Section 9ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 49Introduction to ISO 13485:2016
Lecture 50ISO 13485:2016 Audit Checklist