Advanced Medical Device Development

Name: Advanced Medical Device Development
Rating: 4.4 (61 reviews)

Development of medical devices with an established design through manufacturing, clinical, and regulatory hurtles.

Created byJosh Simon

Last updated 2/2019

English

English [Auto],

What you'll 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

Course content

8 sections • 44 lectures • 5h 52m total length

Introduction to Advanced Medical Device Development9:04
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
Advanced Medical Device Development Forum - Intro Forum0:02
Discussion forum for Advanced MDD topics on the course introduction.

EU Regulatory Basics - EU Regulatory Intro12:47
Description of some basic regulatory terms and concepts in the EU:

* Competent Authority

* Notified Body

* Authorized Representative

* Manufacturer

* CE Mark
EU Regulatory Basics - EU Government Structure and Legislation Process8:27
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 - Medical Device Directives17:45
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 - Tech File and Design Dossier12:33
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 - MDR and IVDR - Definitions15:18
Overview of the new Medical Device Regulation and In Vitro Device Regulation, the latest laws in the EU that deal with medical devices and in vitro diagnostics.
EU Regulatory Basics - MDR/IVDR versus the MDD/AIMDD/IVDD12:36
Similarities and differences between the former device directives and the new current device regulations.
Advanced Medical Device Development Forum - EU Regulatory Topics0:03
Discussion forum for EU Regulatory topics in Advanced MDD course.

Design History File (DHF) Basics14:57
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 Specification Document & Design Matrix8:54
Walking through the steps for filling out a DSD and/or Design Matrix.
Verification and Validation (V&V)13:42
Detailed look at Verification and Validation activities. Examples of both types are given, as well as descriptions on protocols and reports for both phases.
Medical Device Development Discussion Forum - DHF Topics0:02
Discussion forum for topics on the Design History File in the Advanced MDD course.

The Device Master Record4:54
Detailed description of what information is contained within the DMR, along with an example given below.
The Device History Record4:52
Detailed description of the Device History Record along with an example given below.
SOP's and ECO's12:18
Detailed description of the sections of a Standard Operating Procedure (SOP) and the purpose of an Engineering Change Order (ECO).
Engineering Change Order (ECO) Form Template0:01
Device Master Record Template0:02
Advanced Medical Device Development Forum - Device Documentation Topics0:03
Discussion forum for topics on Device Documentation in the Advanced MDD course.

Process Validation Introduction12:35
A first introduction to Process Validation: definition, major regulations that govern it
Process Validation: To Validate, or Not to Validate9:28
Description of when and when not to validate a process in light of regulations from FDA and ISO.
IQ/OQ/PQ9:54
Discussion of the purposes and steps for IQ, OQ, and PQ: Installation Qualification, Operational Qualification, and Performance Qualification
Process Risk Analysis8:34
In-depth look at a Process Failure Modes & Effects Analysis and the context of Process Risk Management.
IQ Protocol Template2:00
PDF Document of a template for an Installation Protocol.
OQ Protocol Template2:00
PDF Document for an OQ Protocol Template
Process FMEA Template2:00
PDF Document for a Process FMEA
Advanced Medical Device Development Forum - Process Validation/Risk Topics0:03
Discussion forum on topics of Process Validation and Process Risk in the Advanced MDD course.

Introduction to Quality12:43
Looking at Quality Systems through the lens of a Systems Approach, Process Approach, and Factual Approach.
How the QSR works9:22
Basic definitions necessary to understand the QSR and how it works.
Applications of the QSR9:57
Gain an understanding of where and when the QSR applies to a company, and when it does not.
Audit and Acceptance Processes19:10
Overview of Management's role according to the QSR, and the process flow for Quality Audits and Acceptance Procedures.
CAPA and Non-conformance12:39
Explore CAPA processes and non-conformance within GMP quality systems, detailing how nonconforming material is identified, investigated, reworked or disposed, and how corrective actions prevent recurrence through documentation and management review.
Advanced Medical Device Development Forum - Quality Systems Topics0:03
Discussion forum for Quality Systems topics in the Advanced MDD course.

Foundations of Clinical Research8:57
Gain familiarity with the documents and events that led to modern day clinical research.
Informed Consent and Institutional Review Boards13:47
Students will gain a summarized overview of 21 CFR parts 50 and 56 for rules regarding patient informed consent and IRB's.
Clinical Trial Roles and Responsibilities17:59
Understand the roles played by the Sponsor, Investigator, and Monitors.
Types of Clinical Trials11:06
Overview of the different types of clinical trials and various parameters defined for each.
Clinical Research Supplemental Notes1:28
Explanation of the attached notes to study for Clinical Research certifications.
Clinical Research Certification Notes50:00
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.
Advanced Medical Device Development Forum - Clinical Trials Topics0:03
Discussion forum for topics on Clinical Trials for medical devices in the Advanced MDD course.

Introduction to the Product Life Cycle12:46
Overview of the Product Life Cycle and the first stage, Discovery & Innovation.
Discovery & Innovation19:26
Detailed look at what innovation is and how it works during the first phase of the Product Life Cycle.
Product Development & Post-Marketing13:37
Learn what happens after commercialization is in full swing, including the functioning of the Product Team.
Advanced Medical Device Development Forum - Product Lifecycle & Management Forum0:03
Discussion forum on Product Lifecycle and Product Management in the Advanced MDD course.

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, 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.

Who this course is for:

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

Advanced Medical Device Development

What you'll learn

Explore related topics

Course content

Introduction to Advanced Medical Device Development2 lectures • 9min

EU Regulatory Basics7 lectures • 1hr 19min

The Design History File - In depth4 lectures • 38min

Device Documentation: DHR, DMR, SOP's, ECO6 lectures • 22min

Process Validation and Process Risk8 lectures • 47min

Quality Systems Management6 lectures • 1hr 4min

Clinical Trials for Medical Devices7 lectures • 1hr 43min

The Product Life Cycle & Product Management4 lectures • 46min

Requirements

Description

Who this course is for: