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Home » US Medical Device Regulatory Affairs Professional Certification Program

US Medical Device Regulatory Affairs Professional Certification Program (MD00S2)

Certification Training
 
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Duration: See individual courses below for time requirements.
Method of Training: Online / Self-paced eLearning.
Credit Hours: See individual courses located below for total credits assigned to this program.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the Biopharma Institute for more information.

Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.

Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Description:

This online certification program provides an introduction to the Code of Federal Regulations (CFRs). It introduces students to the activities that are essential prior to a device being set to go to the United States (US) market. Additionally, it assimilates the knowledge needed in order to execute a quality system in accordance with the 21 CFR PART 820 regulations. The following individual courses are included in this online program: An Introduction to the Regulation of Medical Devices (US and Europe); US 501K Premarket Notification Scheme; and US Quality Systems Requirements, 21 CFR PART 820.

Students can take the final assessment any number of times, as needed, to achieve a passing grade. Once all course requirements have been satisfied, a professional certification has been achieved.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.



Biopharma Institute LogoThe US Medical Device Regulatory Affairs Professional Certification Program includes these individual courses:



Medical Device: US Quality System Requirements (21 CFR PART 820): Implementing a quality system for medical devices can be a complex process. This model will help the student to assimilate all of the required knowledge necessary to impl | Learn more...
Duration: ~1-2 Hours

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 | Learn more...
Duration: ~1-2 Hours

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • 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 course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • 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.
  • Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

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.

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