Advanced Medical Device Development from Udemy

What's inside

Learning objectives

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

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

Syllabus

Gain knowledge of how this course will run and what it will cover

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

Discussion forum for Advanced MDD topics on the course introduction.

Learn about the structure and function of medical device regulations in the EU

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

* Competent Authority

* Notified Body

* Authorized Representative

* Manufacturer

* CE Mark

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.

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.

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.

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.

Similarities and differences between the former device directives and the new current device regulations.

Discussion forum for EU Regulatory topics in Advanced MDD course.

Understand the structure and content of the Design History File (DHF) for a medical device

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.

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

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

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

Understand the relationship between the Device Master Record, Device History Record. Become familiar with the format and purpose of SOP's and Engineering Change Orders.

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

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

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 Template

Device Master Record Template

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

Learn the structure and methods for validating manufacturing processes

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

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

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

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

PDF Document of a template for an Installation Protocol.

PDF Document for an OQ Protocol Template

PDF Document for a Process FMEA

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

Gain thorough understanding of Good Manufacturing Processes and the structure of a Quality System

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

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

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

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

CAPA and Non-conformance

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

Explore the regulations behind Good Clinical Practices (GCP's) and the safe management of human trials.

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

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

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

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

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

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.

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

Understand the stages of the Product Life Cycle and the role of the Product Manager and how this person interacts with all other roles.

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

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

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

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

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Develops practical skills for commercializing medical devices after 'design freeze' to product launch

Examines the medical device approval process in both the US and the EU

Teaches process validation, which is essential for assuring product quality in the medical device industry

Provides insights into the role of the product manager in the medical device lifecycle

Includes discussion forums for interaction and Q&A with fellow learners

Emphasizes quality systems and manufacturing practices, which are crucial for compliance and patient safety

Reviews summary

Promising medical device development course

According to students, Advanced Medical Device Development is a promising course. One student said that they found it interesting, although more reviews are needed to fully evaluate this course.

Interesting lectures and assignments

"Its quite interesting so far"

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Advanced Medical Device Development with these activities:

Design and build a medical device

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Design and build a medical device to apply your learning and solidify concepts

Browse courses on Medical Device Design

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Identify a medical need and develop a concept
Research and select materials and components
Design and prototype the device
Test and evaluate the device
Finalize the design and prepare for manufacturing

Practice Design Verification and Validation Activities

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Reinforce your understanding of verification and validation techniques by completing practice exercises.

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Review the course materials on Verification and Validation.
Identify scenarios where verification or validation is required.
Develop test plans and procedures to verify or validate designs.
Execute the test plans and analyze the results.
Document the verification and validation activities.

Show all two activities

Career center

Learners who complete Advanced Medical Device Development will develop knowledge and skills that may be useful to these careers:

Regulatory Affairs Manager

Regulatory Affairs Managers are responsible for ensuring that medical devices meet regulatory requirements in order to be sold in a particular region. This course provides an in-depth look into the medical device regulatory environment, helping prepare individuals for success in this field.

See salaries and explore the career path for Regulatory Affairs Manager

Design Engineer

Design Engineers are responsible for designing and developing medical devices. This course provides a comprehensive overview of the design process for medical devices, which would be especially useful for someone looking to transition into this field.

See salaries and explore the career path for Design Engineer

Regulatory Affairs Specialist

Regulatory Affairs Specialists ensure that medical devices meet regulatory requirements in order to be sold in a particular region. This course provides an in-depth look into the medical device regulatory environment in the EU, helping prepare individuals for success in this field.

See salaries and explore the career path for Regulatory Affairs Specialist

Clinical Trial Manager

Clinical Trial Managers are responsible for managing clinical trials and ensuring that they are conducted in accordance with regulations. This course provides a comprehensive overview of the management of clinical trials, which would be especially useful for someone looking to transition into this field.

See salaries and explore the career path for Clinical Trial Manager

Validation Engineer

Validation Engineers are responsible for validating medical devices to ensure that they meet regulatory requirements. This course provides an overview of the validation process for medical devices, which would be especially useful for someone looking to transition into this field.

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Product Manager

Product Managers are responsible for the lifecycle of a product, from planning and development to launch and ongoing support. This course provides a detailed overview of the product lifecycle specific to medical devices, which would be especially useful for someone looking to transition into the medical device industry.

See salaries and explore the career path for Product Manager

Clinical Research Associate

Clinical Research Associates are responsible for managing clinical trials and ensuring that they are conducted in accordance with regulations. This course provides a comprehensive overview of Good Clinical Practices and the regulations surrounding management of clinical trials, which can be helpful for someone looking to enter or advance in this field.

See salaries and explore the career path for Clinical Research Associate

Medical Device Sales Representative

Medical Device Sales Representatives work in the medical industry and sell medical devices and equipment. This course helps build a strong understanding of the medical device regulatory environment, which is critical to understanding the needs of customers.

See salaries and explore the career path for Medical Device Sales Representative

Technical Writer

Technical Writers are responsible for creating and managing documentation for medical devices. This course provides an overview of the documentation process for medical devices, which would be especially useful for someone looking to transition into this field.

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Manufacturing Engineer

Manufacturing Engineers are responsible for the manufacturing process of medical devices. This course provides an overview of the manufacturing process and how to validate manufacturing processes, which would be especially useful for someone looking to transition into this field.

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Quality Control Inspector

Quality Control Inspectors are responsible for ensuring that medical devices meet quality standards. This course helps build a foundation for the quality management of medical devices, which could be helpful for someone looking to enter or advance in this field.

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Project Manager

Project Managers are responsible for planning, executing, and closing projects. This course provides an overview of the project management process for medical devices, which would be especially useful for someone looking to transition into this field.

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Medical Writer

Medical Writers are responsible for creating and managing content for medical devices. This course provides an overview of the medical writing process for medical devices, which would be especially useful for someone looking to transition into this field.

See salaries and explore the career path for Medical Writer

Quality Assurance Auditor

Quality Assurance Auditors are responsible for auditing quality management systems to ensure that they meet regulatory requirements. This course helps build a foundation in the field of quality management for medical devices and may be especially useful for someone looking to enter this field later in their career.

See salaries and explore the career path for Quality Assurance Auditor

Quality Assurance Manager

Quality Assurance Managers lead and administer quality assurance systems and are responsible for the organization's product and service quality. This course helps build a foundation in the field of quality management for medical devices and may be especially useful for someone looking to enter this field later in their career.

See salaries and explore the career path for Quality Assurance Manager