Advanced Medical Device Development
Advanced Medical Device Development, available at $199.99, has an average rating of 4.3, with 44 lectures, based on 60 reviews, and has 244 subscribers.
You will learn about Understand the processes for medical device development after "design freeze" Become familiar with the European regulatory framework for medical devices Gain an understanding of manufacturing process validation Build on the student's current understanding of the Quality Management System Understand key aspects of Product Management both during and after product launch Discuss Good Clinical Practices and regulations surrounding management of clinical trials This course is ideal for individuals who are Engineers with some basic medical device design experience or Anyone who needs an early primer on medical device manufacturing process development or Students interested in pursuing medical device development or Physicians and Professors with device ideas that need instruction on how to get there or Medical device project team members that need basic primers on clinical and regulatory practices It is particularly useful for Engineers with some basic medical device design experience or Anyone who needs an early primer on medical device manufacturing process development or Students interested in pursuing medical device development or Physicians and Professors with device ideas that need instruction on how to get there or Medical device project team members that need basic primers on clinical and regulatory practices.
Enroll now: Advanced Medical Device Development
Summary
Title: Advanced Medical Device Development
Price: $199.99
Average Rating: 4.3
Number of Lectures: 44
Number of Published Lectures: 44
Number of Curriculum Items: 44
Number of Published Curriculum Objects: 44
Original Price: $199.99
Quality Status: approved
Status: Live
What You Will Learn
- Understand the processes for medical device development after "design freeze"
- Become familiar with the European regulatory framework for medical devices
- Gain an understanding of manufacturing process validation
- Build on the student's current understanding of the Quality Management System
- Understand key aspects of Product Management both during and after product launch
- Discuss Good Clinical Practices and regulations surrounding management of clinical trials
Who Should Attend
- Engineers with some basic medical device design experience
- Anyone who needs an early primer on medical device manufacturing process development
- Students interested in pursuing medical device development
- Physicians and Professors with device ideas that need instruction on how to get there
- Medical device project team members that need basic primers on clinical and regulatory practices
Target Audiences
- Engineers with some basic medical device design experience
- Anyone who needs an early primer on medical device manufacturing process development
- Students interested in pursuing medical device development
- Physicians and Professors with device ideas that need instruction on how to get there
- Medical device project team members that need basic primers on clinical and regulatory practices
This course is a continuation of Medical Device Development. Topics cover the primary events that occur from just before “design freeze” of a medical device up through clinical evaluation and commercial launch. Significant emphasis is placed on Quality Systems and Manufacturing, with attention to regulatory and legal compliance as well as design concepts.
The course begins by supplementing already existing US Regulatory knowledge with the basics of medical device regulation in the EU, specifically the Medical Device Regulation (MDR) and In Vitro Devices Regulation (IVDR). This discussion then carries on to post-design activities, such as finishing construction of the Design History File and the first steps of commercialization.
Once the device has entered to market, changes are often required to the manufacturing process and the device itself. Methods for enacting these changes and validating the resulting new processes are discussed.
Finally the course ends with a deep discussion on post-market activities in relation to Product Management and clinical trials. The necessary regulations for running human studies are covered in detail, along with a description of the Product Manager’s role in making the activities come together.
Course Curriculum
Chapter 1: Introduction to Advanced Medical Device Development
Lecture 1: Introduction to Advanced Medical Device Development
Lecture 2: Advanced Medical Device Development Forum – Intro Forum
Chapter 2: EU Regulatory Basics
Lecture 1: EU Regulatory Basics – EU Regulatory Intro
Lecture 2: EU Regulatory Basics – EU Government Structure and Legislation Process
Lecture 3: EU Regulatory Basics – Medical Device Directives
Lecture 4: EU Regulatory Basics – Tech File and Design Dossier
Lecture 5: EU Regulatory Basics – MDR and IVDR – Definitions
Lecture 6: EU Regulatory Basics – MDR/IVDR versus the MDD/AIMDD/IVDD
Lecture 7: Advanced Medical Device Development Forum – EU Regulatory Topics
Chapter 3: The Design History File – In depth
Lecture 1: Design History File (DHF) Basics
Lecture 2: Design Specification Document & Design Matrix
Lecture 3: Verification and Validation (V&V)
Lecture 4: Medical Device Development Discussion Forum – DHF Topics
Chapter 4: Device Documentation: DHR, DMR, SOP's, ECO
Lecture 1: The Device Master Record
Lecture 2: The Device History Record
Lecture 3: SOP's and ECO's
Lecture 4: Engineering Change Order (ECO) Form Template
Lecture 5: Device Master Record Template
Lecture 6: Advanced Medical Device Development Forum – Device Documentation Topics
Chapter 5: Process Validation and Process Risk
Lecture 1: Process Validation Introduction
Lecture 2: Process Validation: To Validate, or Not to Validate
Lecture 3: IQ/OQ/PQ
Lecture 4: Process Risk Analysis
Lecture 5: IQ Protocol Template
Lecture 6: OQ Protocol Template
Lecture 7: Process FMEA Template
Lecture 8: Advanced Medical Device Development Forum – Process Validation/Risk Topics
Chapter 6: Quality Systems Management
Lecture 1: Introduction to Quality
Lecture 2: How the QSR works
Lecture 3: Applications of the QSR
Lecture 4: Audit and Acceptance Processes
Lecture 5: CAPA and Non-conformance
Lecture 6: Advanced Medical Device Development Forum – Quality Systems Topics
Chapter 7: Clinical Trials for Medical Devices
Lecture 1: Foundations of Clinical Research
Lecture 2: Informed Consent and Institutional Review Boards
Lecture 3: Clinical Trial Roles and Responsibilities
Lecture 4: Types of Clinical Trials
Lecture 5: Clinical Research Supplemental Notes
Lecture 6: Clinical Research Certification Notes
Lecture 7: Advanced Medical Device Development Forum – Clinical Trials Topics
Chapter 8: The Product Life Cycle & Product Management
Lecture 1: Introduction to the Product Life Cycle
Lecture 2: Discovery & Innovation
Lecture 3: Product Development & Post-Marketing
Lecture 4: Advanced Medical Device Development Forum – Product Lifecycle & Management Forum
Instructors
-
Josh Simon
Medical Device Development Professional
Rating Distribution
- 1 stars: 0 votes
- 2 stars: 1 votes
- 3 stars: 8 votes
- 4 stars: 22 votes
- 5 stars: 29 votes
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