|Credits: 1 CPD Credits|
Length of Course: Approximate time to complete this course is 1 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $195.00
Training Program: An Introduction to the Regulation of Medical Devices
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
This program provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.
Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can take the final assessment any number of times, as needed, in order to achieve a passing grade.
Benefits of Getting Certified at BioPharma Institute
The BioPharma Institute is an online learning solution for professionals working within the healthcare, biotech, and pharmaceutical industries. Through the years, we have compiled a comprehensive offering of online books, recorded seminars, live seminars, and other tools used in our online courses to teach the various aspects of applications and precise job functions found within these industries. We are proud to serve thousands of corporations, both abroad and within the United States, and can be a trusted ally to you and your company.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The An Introduction to the Regulation of Medical Devices course is found in the following professional certification program(s):
An outline of the module's scope and objectives, and notes on terminology.
Medical devices and their regulation
In this session we explain what medical devices are and how they differ from medicinal products. We define various special categories of such devices. We identify basic principles of their regulation, including risk classification. We outline requirements for technical documentation, clinical data, and post-market surveillance and vigilance. Finally, we identify the major players in regulation.
Regulation of medical devices in the USA
In this session we outline prominent characteristics of the regulation of medical devices in the USA.
Regulation of medical devices in Europe
In this session we outline prominent characteristics of the regulation of medical devices in the European Economic Area.
Multiple-choice mastery assessment.
Who will benefit from this module?
This module provides essential training for all personnel concerned with the development, regulatory compliance, or marketing of medical devices. It is especially suitable for induction training of entry-level staff.
-Define and give examples of the various categories of medical device
-Outline the principles of medical device regulation and the criteria for placing devices on the market
-Identify major players in the regulation of medical devices worldwide
-Identify legal statutes and sources of regulatory guidance on medical devices in the European Union and the USA
-Outline prominent characteristics of the regulation of medical devices in the USA
-Outline prominent characteristics of the regulation of medical devices in the European Economic Area
All Courses in the Medical Devices Catalog:
|Medical Device Regulatory Affairs: Australian Overview: This online program is an overview of Australian regulatory affairs. The course objectives are to describe the systems of classification for medical devices; define the roles of the regulator, manufacturer, and ... Learn more|
|Medical Device Regulatory Affairs: Australian Requirements for Registration: This is an online program offers training with immediate access upon enrollment. The students will be introduced to the specifics that are required before a medical device is qualified to go to market. The prog ... Learn more|
|Medical Device Regulatory Affairs: Global: This is an online program offering training with immediate access upon enrollment. Medical devices are globally regulated by a series of regulations and rules designed to produce an effective and safe device. T ... Learn more|
|Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements: This course details the regulatory expectations for quality management system (QMS) certification, identifies vital elements of the essential and standard administration roles, and explains how ISO 13485:2003 ( ... Learn more|
|Medical Device Regulatory Affairs: Global Risk Management: This online program explains relevant risk management terminology. The course identifies the process of risk management, details all of the documentation required, and discusses how risk can be calculated. Cour ... Learn more|
|Medical Device Quality Management: Managing a QMS: This course teaches the student about the maintenance of a quality management system (QMS). Course objectives include training how to recognize the importance of measuring performance, illustrating how the inte ... Learn more|
|Medical Device Quality Management: Documentation and Records: Control, implementation, and development of documentation and records provide the foundation of a quality management system (QMS). It also provides the evidence of compliance with the FDA CFR 820 Quality System ... Learn more|
|Medical Device Quality Management: CAPA Systems: The ability to correct and identify existing problems and implement controls to prevent potential problems is essential for efficient quality management processes, safety products, and continued customer satisf ... Learn more|
|Medical Device Regulatory Affairs: US Overview: The medical device industry in the USA is governed by a number of important regulations, the most important of those being contained within the CFRs (code of federal regulations) - 21 CFR part 800 series. This ... Learn more|
|Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820: Implementing a quality system for medical devices can be a complex process. This model will help you to assimilate all of the required knowledge necessary to implement a quality system in accordance with the 21 ... Learn more|
|Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme: This course introduces the student to the required activities necessary before a device is ready to go to market in the United States. The US Regulatory Affairs Overview (MDU1) course is recommended as an intro ... Learn more|
|An Introduction to the Regulation of Medical Devices: This program provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.
We explain what me ... Learn more|
Online Training: The Benefits of eLearning
- Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.