Duration: 1.5 hours, Online (the average time to complete the training program, including final assessments).Credits Hours: 1
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 $149.00
Training Program: Medical Device Regulatory Affairs: Global
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
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. This online course guides you through an overview of regulations that apply to global medical devices. This course is also found in the Global Medical Device Regulatory Affairs Professional Certification Program. The objectives of this course are to outline the steps needed to obtain a manufacturer license, outline the steps needed to ensure that a device meets registration requirements, identify the regulatory requirements during the lifecycle of a product, to identify the major regulatory agencies, recognize the classification system of medical devices, and will define the term 'medical devices'.
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
By employing advanced e-learning training techniques, and coupling them with automated tracking systems, the BioPharma Institute is helping companies, both abroad and within the US, by maintaining training records, teaching their employees, and improving their overall service quality. We can assist you, your colleagues, or your employees to succeed and advance corporate and career objectives.
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 Medical Device Regulatory Affairs: Global course is found in the following professional certification program(s):
6. Regulatory Bodies and Important Agencies
8. Classification of Medical Devices
9. Factors in Classification
11. Medical Device Life Cycle
Define the term medical devices.
Describe the medical device classification system.
Recognize that medical device classification systems are based on risk.
Identify the major regulatory agencies.
Identify the regulatory requirements during a product`s lifecycle.
Outline the steps required to ensure that a device meets registration requirements.
Outline the steps required to obtain a license to manufacture.
Online Training Program Benefits:
- 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.