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Thursday, November 26, 2020
Home » Global Medical Device Regulatory Affairs Professional Certification Program

Global Medical Device Regulatory Affairs Professional Certification Program (MD00S1)

Certification Training
Rated 4.44/5
9 reviews
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.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $395.00

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

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute


This Global Medical Device Regulatory Affairs Professional Certification Program is an online program which guides the student through a global medical device regulations overview. It discusses how ISO13485:2003 (the ISO standard) relates to the industry of medical devices, details the regulatory expectations for quality management system (QMS) certification, and identifies vital elements of the essential and standard administration rules. It presents and discusses the key differences between ISO13485 and ISO9000, and as they apply to QMS medical devices. The course identifies the risk management process, explains the terminology, details the required documentation, and discusses how risk can be calculated.

The following three areas of training are included in the program: An Introduction to the Regulation of Medical Devices; Global Risk Management; and Requirements of Global Quality Management Systems. Once course requirements have been satisfied a Certificate of Completion will be made available.

Benefits of Getting Certified at BioPharma Institute

BioPharma Institute has been in existence for over two decades has become one of the top online training institutes for professionals who work in the pharmaceutical, biotechnology, and healthcare industries. Thousands of businesses have been aided by our high-quality instruction, courses, and techniques. Major players in the industry are just a sampling of the companies with whom we have worked. Our certifications are recognized in a large spectrum of industries and our training solutions can be customized to meet the needs of most organizations.

BioPharma Institute has a state-of-the-art e-learning system which makes online learning easy. We provide various educational implements to help students learn the essential aspects of the industry. No matter if your organization is a large-scale operation or a small-scale business, whether you need to train new employees or take a refresher course, our exceptional industry knowledge and infinite resources deliver supreme training for you, your employees, and your colleagues.

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.

Biopharma Institute LogoThe Global Medical Device Regulatory Affairs 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 E | Learn more...
Duration: 1 CPD Credit Hours

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

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 di | 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, or email

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