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Tuesday, October 15, 2019
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Medical Device Quality Management Professional Certification Program (MD00S3)

Certification Training
Rated 4.43/5
7 reviews
Duration: 6.4 hours, Online (the average time to complete the training program, including final assessments).
Credit Hours: See individual courses for credit hours assigned.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $639.00
BioPharma Institute ReviewsDescription:

This online certification program supplies an introduction to the requirements of a Corrective and Preventive Action (CAPA) system; provides a description of how to identify existing problems, correct them, and execute controls that will help to prevent possible problems; describes the essentials necessary for an efficient quality management process, safe products, and continued customer satisfaction. The student will be introduced to medical device records, requirements, and their documentation; as well as their controls. The course taker will also be educated as to the control, implementation, and development of how records and documentation provide the foundation of a Quality Management System, such as compliance with ISO 13485 standards and the FDA CFR 820 QSRs (Quality System Regulations). Those taking this course will be educated on the maintenance and requirements involving a QMS (Quality Management System). The following individual courses are included in this online program: An Introduction to the Regulation of Medical Devices; CAPA Systems; Documentation and Records; and Managing a QMS.

Once all course requirements have been satisfied, a Professional Certification has been achieved. 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

If you seek a method through which to train your employees economically without having to set aside an entire day for them to attend a live course, we here at BioPharma Institute are a training partner you can rely on. We will cater to both small-scale and large-scale training requests, customizing your and your employees education. Throughout many of our courses, students will engage in active learning through the help of videos, recorded and live seminars, books, and more.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

Training Provided By: BioPharma Institute

BioPharma Institute LogoThe Medical Device Quality Management Professional Certification Program includes these individual courses:

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

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

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

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