Medical Device Regulations
Medical Device Regulations, available at $54.99, has an average rating of 4.04, with 46 lectures, based on 159 reviews, and has 1638 subscribers.
You will learn about Learn how medical devices go from idea to product Understand the 510K and PMA submission process for medical devices FDA regulatory pathways including 510K, PMA, De Novo, IDE, HDE Risk management and quality in device development Learn how to research new devices and companies Understand medical device career paths and opportunities This course is ideal for individuals who are Aspiring regulatory affairs specialists, project managers, subject matter experts and consultants or Entrepreneurs planning to bring a new medical device to market and need to know how to get started or Project managers interested in developing their knowledge of medical device projects or Graduate or undergraduate students wishing to deepen their knowledge of medical devices or Recently graduated engineers wishing to pursue a career in medical devices It is particularly useful for Aspiring regulatory affairs specialists, project managers, subject matter experts and consultants or Entrepreneurs planning to bring a new medical device to market and need to know how to get started or Project managers interested in developing their knowledge of medical device projects or Graduate or undergraduate students wishing to deepen their knowledge of medical devices or Recently graduated engineers wishing to pursue a career in medical devices.
Enroll now: Medical Device Regulations
Summary
Title: Medical Device Regulations
Price: $54.99
Average Rating: 4.04
Number of Lectures: 46
Number of Published Lectures: 46
Number of Curriculum Items: 46
Number of Published Curriculum Objects: 46
Original Price: $199.99
Quality Status: approved
Status: Live
What You Will Learn
- Learn how medical devices go from idea to product
- Understand the 510K and PMA submission process for medical devices
- FDA regulatory pathways including 510K, PMA, De Novo, IDE, HDE
- Risk management and quality in device development
- Learn how to research new devices and companies
- Understand medical device career paths and opportunities
Who Should Attend
- Aspiring regulatory affairs specialists, project managers, subject matter experts and consultants
- Entrepreneurs planning to bring a new medical device to market and need to know how to get started
- Project managers interested in developing their knowledge of medical device projects
- Graduate or undergraduate students wishing to deepen their knowledge of medical devices
- Recently graduated engineers wishing to pursue a career in medical devices
Target Audiences
- Aspiring regulatory affairs specialists, project managers, subject matter experts and consultants
- Entrepreneurs planning to bring a new medical device to market and need to know how to get started
- Project managers interested in developing their knowledge of medical device projects
- Graduate or undergraduate students wishing to deepen their knowledge of medical devices
- Recently graduated engineers wishing to pursue a career in medical devices
The medical device industry is growing rapidly, providing great opportunities for innovators, experts and entrepreneurs. This course will provide a detailed overview of the way in which new devices go from concept to product, providing you with a starting point to develop a deep understanding of this complex and fast-moving business space.
We will cover all of the key components of bringing a new device to market, including:
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Paths to Market, including the 510K, PMA, HDE and other commonly used pathways
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Clinical trials of medical devices, including IDE, submissions, records and reporting
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Risk management and quality in device development
During this course we will also cover the publicly available information sources that will enable you to research device companies and understand their value. We will cover medical device databases that allow you to research marketed medical devices. We will cover clinical trial databases that allow you to research planned and ongoing trials of medical devices. Links to these freely available resources will be provided.
This course will be a valuable resource for anyone interested in developing their basic knowledge of the medical device industry. For students and recent graduates in medical device engineering, this course will help you develop a knowledge of the industry and the regulatory steps that companies use to bring new innovations to market. For project managers, this course can help you to learn about this industry and equip you to manage medical device development projects. For professionals working in related fields, this course will provide an overview of the medical device industry.
Course Curriculum
Chapter 1: Introduction
Lecture 1: Introduction
Lecture 2: Medical Device Industry
Lecture 3: Researching Medical Device Companies
Lecture 4: Medical Device Careers
Chapter 2: Regulation of Medical Devices
Lecture 1: MD100 Medical Devices Overview
Lecture 2: MD110 Medical Devices Definitions
Lecture 3: MD115 Medical Device Regulations
Lecture 4: MD120 Medical Device Regulations History
Lecture 5: MD130 FDA History
Lecture 6: FDA Regulations
Chapter 3: Path to Market
Lecture 1: MD200 Path to Market
Lecture 2: MD210 Device Classification
Lecture 3: MD230 510K and PMA
Lecture 4: MD232 Predicates
Lecture 5: MD234 FDA Databases
Chapter 4: Clinical Trials
Lecture 1: MD300 Clinical Trials
Lecture 2: MD310 Investigational Device Exemptions (IDEs)
Lecture 3: MD330 IDE Submissions
Lecture 4: MD340 IDE Records & Reporting
Lecture 5: MD350 Researching Clinical Trials
Chapter 5: Quality Systems
Lecture 1: MD400 Quality Systems
Lecture 2: MD405 Risk Management
Lecture 3: MD410 GXP
Lecture 4: MD412 GLP
Lecture 5: MD414 GCP
Lecture 6: MD416 GMP
Lecture 7: MD418 Supply Chain
Lecture 8: MD420 Design Controls
Lecture 9: MD430 Design Inputs
Lecture 10: MD440 Design Outputs
Lecture 11: MD450 Verification and Validation
Lecture 12: MD460 Design Transfer
Lecture 13: MD470 Design Changes
Lecture 14: MD480 Documentation
Chapter 6: Medical Device Submissions
Lecture 1: MD500 Medical Device Submissions
Lecture 2: MD510 FDA Interactions
Lecture 3: MD520 510K Submissions
Lecture 4: MD530 510K Content
Lecture 5: MD540 510K Abbreviated
Lecture 6: MD550 510K Special
Lecture 7: MD580 PMA Submissions
Lecture 8: MD590 Change Communication
Chapter 7: Post-Market Surveillance
Lecture 1: MD600 Post Market Surveillance
Lecture 2: MD610 MDR
Lecture 3: MD620 Recalls
Lecture 4: MD630 522 Postmarket
Instructors
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SequenceCentral – IT Training and Consulting
– IT Training and Consulting -
Steve Ayers
PhD, MSc, PMP, CISSP, CCSP
Rating Distribution
- 1 stars: 5 votes
- 2 stars: 8 votes
- 3 stars: 37 votes
- 4 stars: 46 votes
- 5 stars: 63 votes
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