Medical Device Development

Medical Device Development, available at $199.99, has an average rating of 4.1, with 49 lectures, based on 92 reviews, and has 241 subscribers.

You will learn about Function as a member of a medical device project team Understand the various disciplines involved with medical device development Know the roles that different departments and professions play in medical device development Describe the regulatory structure for medical devices in the USA Use this information in choosing a medical device profession This course is ideal for individuals who are Biomedical Engineering (or other STEM majors) that want to know what medical device development in industry is like or Academics that need to understand the difference between Industry and Academia or Physicians that have a medical device idea and wish to know the basics of how to get started or People fresh out of college that need a basic primer on device development for their job or Graduate and Undergraduate students whose schools do not offer courses like this one or Medical Device Engineers with 0 to 2 years of experience that need a basic education about the various roles in device development or This course is NOT for seasoned medical device project professionals It is particularly useful for Biomedical Engineering (or other STEM majors) that want to know what medical device development in industry is like or Academics that need to understand the difference between Industry and Academia or Physicians that have a medical device idea and wish to know the basics of how to get started or People fresh out of college that need a basic primer on device development for their job or Graduate and Undergraduate students whose schools do not offer courses like this one or Medical Device Engineers with 0 to 2 years of experience that need a basic education about the various roles in device development or This course is NOT for seasoned medical device project professionals.

Enroll now: Medical Device Development

Summary

Title: Medical Device Development

Price: $199.99

Average Rating: 4.1

Number of Lectures: 49

Number of Published Lectures: 49

Number of Curriculum Items: 49

Number of Published Curriculum Objects: 49

Original Price: $199.99

Quality Status: approved

Status: Live

What You Will Learn

Function as a member of a medical device project team
Understand the various disciplines involved with medical device development
Know the roles that different departments and professions play in medical device development
Describe the regulatory structure for medical devices in the USA
Use this information in choosing a medical device profession

Who Should Attend

Biomedical Engineering (or other STEM majors) that want to know what medical device development in industry is like
Academics that need to understand the difference between Industry and Academia
Physicians that have a medical device idea and wish to know the basics of how to get started
People fresh out of college that need a basic primer on device development for their job
Graduate and Undergraduate students whose schools do not offer courses like this one
Medical Device Engineers with 0 to 2 years of experience that need a basic education about the various roles in device development
This course is NOT for seasoned medical device project professionals

Target Audiences

Biomedical Engineering (or other STEM majors) that want to know what medical device development in industry is like
Academics that need to understand the difference between Industry and Academia
Physicians that have a medical device idea and wish to know the basics of how to get started
People fresh out of college that need a basic primer on device development for their job
Graduate and Undergraduate students whose schools do not offer courses like this one
Medical Device Engineers with 0 to 2 years of experience that need a basic education about the various roles in device development
This course is NOT for seasoned medical device project professionals

This course will provide a detailed overview of medical device development from a realistic industrial perspective using recorded lectures and slides which are all provided. The processes used in corporations to conceive and develop devices will be explored from a research, regulatory, clinical, QA/QC, marketing, engineering, and legal perspective under the umbrella of project management techniques. Material will be presented as an aide to students who wish to decide on careers in either industry or academia.�

For students or newly minted engineers that find themselves participating on project teams, this course will give them basic knowledge needed to function.�

For Professors interested in making a change or learning more about their commercial counterparts, this course will bridge the knowledge gap and convey an understanding of what accommodations can be made to do that.�

Anyone that needs an overview of the major roles found in device companies can benefit from this course.�

Course Curriculum

Chapter 1: Introduction to Medical Device Development – Academia vs. Industry

Lecture 1: Introduction to Medical Device Development

Lecture 2: Medical Device Development Discussion Forum – Introduction Forum

Chapter 2: Project Management for Medical Devices – How Corporations Manage Projects

Lecture 1: Project Management 101

Lecture 2: Project LIfecycle and Initiation

Lecture 3: Project Planning

Lecture 4: Project Executing, Control, and Closing

Lecture 5: Medical Device Development Discussion Forum – Project Management Topics

Chapter 3: Pre-clinical Device Development – Research projects

Lecture 1: Pre-Clinical Research Projects

Lecture 2: Managing in vivo Studies

Lecture 3: Medical Device Development Discussion Forum – Pre-Clinical Development Topics

Chapter 4: Regulatory Basics for Medical Devices

Lecture 1: Regulatory Considerations and the FDA

Lecture 2: Regulation of Medical Devices in the USA

Lecture 3: Role of The Regulatory Department

Lecture 4: Medical Device Development Discussion Forum – Regulatory Topics

Chapter 5: Quality Control and Quality Assurance

Lecture 1: Quality Control and Quality Assurance

Lecture 2: The Quality System

Lecture 3: Medical Device Development Discussion Forum – QA/QC Topics

Chapter 6: Business 101 – What makes corporations tick and research labs tock

Lecture 1: Business 101

Lecture 2: Types of Corporations, Part 1

Lecture 3: Types of Corporations, Part 2

Lecture 4: Analyzing Companies

Lecture 5: Medical Device Development Discussion Forum – Business Topics

Chapter 7: Marketing medical devices, and the basics of sales forces

Lecture 1: Marketing and Sale of Medical Devices

Lecture 2: Marketing Strategy and Mix

Lecture 3: Role of the Marketing Department

Lecture 4: Product Management

Lecture 5: The Basics of Sales Forces

Lecture 6: Medical Device Development Discussion Forum – Marketing and Sales Topics

Chapter 8: Clinical Research

Lecture 1: Clinical trials, CRA’s, and CRO’s

Lecture 2: Roles in Clinical Trials

Lecture 3: Medical Device Development Discussion Forum – Basic Clinical Research Topics

Chapter 9: Design Controls 101

Lecture 1: Design Controls Part 1: DHF, Proposal, DDP, Inputs, Outputs, Specifications

Lecture 2: Design Controls Part 2: Design Verification

Lecture 3: Design Controls Part 2: Design Validation

Lecture 4: Design Controls Part 2: Design Transfer, Review, and Change

Lecture 5: Design Controls Document Templates – PDF

Lecture 6: Design Controls Document Template – DDP

Lecture 7: Design Controls Document Template – DID

Lecture 8: Design Controls Document Template – DSD

Lecture 9: Medical Device Development Discussion Forum – Design Controls Topics

Chapter 10: Risk Analysis for Medical Devices

Lecture 1: Risk Analysis: FMECA, Risk analysis document

Lecture 2: Risk Analysis Document Template – Risk Analysis Instructions

Lecture 3: Risk Analysis Document Template – Risk Analysis Template

Lecture 4: Medical Device Development Discussion Forum – Risk Topics

Chapter 11: Organizational Development in Device Companies

Lecture 1: Organization types, putting together project teams

Lecture 2: Project Management vs. Design Controls

Lecture 3: Medical Device Development Discussion Forum – Organizational Development Topics

Chapter 12: Consultants and Some Legal Basics

Lecture 1: Consultants – Role in medical device development, Anti- kickback statute

Lecture 2: Medical Device Development Discussion Forum – Consultants/Legal Basics Topics

Instructors

Josh Simon
Medical Device Development Professional

Rating Distribution

1 stars: 2 votes
2 stars: 2 votes
3 stars: 22 votes
4 stars: 31 votes
5 stars: 35 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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