Advanced Medical Device Development
4.8 (9 ratings)
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Advanced Medical Device Development

Development of medical devices with an established design through manufacturing, clinical, and regulatory hurtles.
4.8 (9 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
62 students enrolled
Created by Josh Simon
Last updated 1/2017
English
Price: $200
30-Day Money-Back Guarantee
Includes:
  • 5.5 hours on-demand video
  • 10 Articles
  • 6 Supplemental Resources
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I 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
View Curriculum
Requirements
  • All of the content from course entitled Medical Device Development OR
  • One year or more experience as a project team member for a medical device company
Description

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. 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.

Who is the target audience?
  • 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
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Curriculum For This Course
42 Lectures
06:14:26
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Introduction to Advanced Medical Device Development
2 Lectures 09:04

First introduction and overview of the course. At the end, students will be able to:

* Gain an introduction to the course instructor

* Know who should and should not take this course

* Know what this course will cover

Preview 09:00

Discussion forum for Advanced MDD topics on the course introduction.

Advanced Medical Device Development Forum - Intro Forum
00:04
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EU Regulatory Basics
5 Lectures 45:57

Description of some basic regulatory terms and concepts in the EU:

* Competent Authority

* Notified Body

* Authorized Representative

* Manufacturer

* CE Mark

Preview 10:55

Gain an understanding of the overall structure of the EU Government and how it proposes and adopts legislation. These rules, known as Directives, are then fulfilled by the member states.

EU Regulatory Basics - EU Government Structure and Legislation Process
07:03

Overview of the three different medical device directives:

93/42/EEC - Medical Device Directive (MDD)

98/79/EC - In vitro Diagnostic Directive (IVDD)

90/385/EEC - Active Implantable Medical Device Directive (AIMDD)

NOTE: Check back with this lecture in late 2015 to see changes for new EU directives to issue.

EU Regulatory Basics - Medical Device Directives
17:26

Description of content that goes into a Tech File and a Design Dossier. Outlines the structure of the files and how they are used to gain approval (CE Marking) for a device in the EU.

EU Regulatory Basics - Tech File and Design Dossier
10:29

Discussion forum for EU Regulatory topics in Advanced MDD course.

Advanced Medical Device Development Forum - EU Regulatory Topics
00:04
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The Design History File - In depth
4 Lectures 37:37

A detailed description of the what, why, and how of a DHF. Outlines the structure of the document, what pieces make it up, and how the DHF fit into the flow of device documentation. A detailed comparison between the DHF and the European Tech File/Design Dossier is also explored.

Design History File (DHF) Basics
14:57

Walking through the steps for filling out a DSD and/or Design Matrix.

Design Specification Document & Design Matrix
08:54

Detailed look at Verification and Validation activities. Examples of both types are given, as well as descriptions on protocols and reports for both phases.

Verification and Validation (V&V)
13:42

Discussion forum for topics on the Design History File in the Advanced MDD course.

Medical Device Development Discussion Forum - DHF Topics
00:04
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Device Documentation: DHR, DMR, SOP's, ECO
6 Lectures 22:11

Detailed description of what information is contained within the DMR, along with an example given below.

The Device Master Record
04:54

Detailed description of the Device History Record along with an example given below.

The Device History Record
04:52

Detailed description of the sections of a Standard Operating Procedure (SOP) and the purpose of an Engineering Change Order (ECO).

SOP's and ECO's
12:18

Engineering Change Order (ECO) Form Template
00:01

Device Master Record Template
00:02

Discussion forum for topics on Device Documentation in the Advanced MDD course.

Advanced Medical Device Development Forum - Device Documentation Topics
00:04
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Process Validation and Process Risk
8 Lectures 40:35

A first introduction to Process Validation: definition, major regulations that govern it

Process Validation Introduction
12:35

Description of when and when not to validate a process in light of regulations from FDA and ISO.

Process Validation: To Validate, or Not to Validate
09:28

Discussion of the purposes and steps for IQ, OQ, and PQ: Installation Qualification, Operational Qualification, and Performance Qualification

IQ/OQ/PQ
09:54

In-depth look at a Process Failure Modes & Effects Analysis and the context of Process Risk Management.

Process Risk Analysis
08:34

PDF Document of a template for an Installation Protocol.

IQ Protocol Template
2 pages

PDF Document for an OQ Protocol Template

OQ Protocol Template
2 pages

PDF Document for a Process FMEA

Process FMEA Template
2 pages

Discussion forum on topics of Process Validation and Process Risk in the Advanced MDD course.

Advanced Medical Device Development Forum - Process Validation/Risk Topics
00:04
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Quality Systems Management
6 Lectures 01:03:55

Looking at Quality Systems through the lens of a Systems Approach, Process Approach, and Factual Approach.

Introduction to Quality
12:43

Basic definitions necessary to understand the QSR and how it works.

How the QSR works
09:22

Gain an understanding of where and when the QSR applies to a company, and when it does not.

Applications of the QSR
09:57

Overview of Management's role according to the QSR, and the process flow for Quality Audits and Acceptance Procedures.

Audit and Acceptance Processes
19:10

CAPA and Non-conformance
12:39

Discussion forum for Quality Systems topics in the Advanced MDD course.

Advanced Medical Device Development Forum - Quality Systems Topics
00:04
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Clinical Trials for Medical Devices
7 Lectures 53:21

Gain familiarity with the documents and events that led to modern day clinical research.

Foundations of Clinical Research
08:57

Students will gain a summarized overview of 21 CFR parts 50 and 56 for rules regarding patient informed consent and IRB's.

Informed Consent and Institutional Review Boards
13:47

Understand the roles played by the Sponsor, Investigator, and Monitors.

Clinical Trial Roles and Responsibilities
17:59

Overview of the different types of clinical trials and various parameters defined for each.

Types of Clinical Trials
11:06

Explanation of the attached notes to study for Clinical Research certifications.

Clinical Research Supplemental Notes
01:28

A 50-page e-book that summarizes in bullet point form all of the regulations needed for conduction of clinical research, and those that are most asked about on clinical research certification exams.

Clinical Research Certification Notes
50 pages

Discussion forum for topics on Clinical Trials for medical devices in the Advanced MDD course.

Advanced Medical Device Development Forum - Clinical Trials Topics
00:04
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The Product Life Cycle & Product Management
4 Lectures 45:53

Overview of the Product Life Cycle and the first stage, Discovery & Innovation.

Introduction to the Product Life Cycle
12:46

Detailed look at what innovation is and how it works during the first phase of the Product Life Cycle.

Discovery & Innovation
19:26

Learn what happens after commercialization is in full swing, including the functioning of the Product Team.

Product Development & Post-Marketing
13:37

Discussion forum on Product Lifecycle and Product Management in the Advanced MDD course.

Advanced Medical Device Development Forum - Product Lifecycle & Management Forum
00:04
About the Instructor
Josh Simon
4.5 Average rating
160 Reviews
3,394 Students
6 Courses
Medical Device Development Professional

Currently, I am Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology. For over 10 years, I have worked in various roles developing medical devices and have touched perhaps hundreds of them in varying capacities from concept to launch.

As someone that loves to give back and feels obligated to teach those that are coming after me in the medical device industry, I have always said that it is important to excel in at least two things. Every day I try to be an example to my coworkers and students by using my experience in research and business to bridge the gap between the two. This usually involves conversations from all perspectives covering project management, medical device product development, marketing, training, and research planning. Being able to explain tough concepts to audiences without background in a subject has been my forte, and I have used it in numerous device companies, sales training classes, CME, and Grand Rounds presentations around the world. Going the other way, I have conveyed crucial business strategies to motivate product development and research professionals both in industry and academia. While my formal training is in general business and Biomedical Engineering with specific interest in bone tissue engineering and biomaterials, I see myself as a translator. The languages of business and science are not often mutually understood, and I act as the intermediary.