|Program/Course ID: MDA0|
Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $195.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: Introduction to the Regulation of Medical Devices
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials 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.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
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.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Purchase orders (POs): If a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.