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ISO 13485:2016 Training and Professional Certification Programs


Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma Institute

Biopharma Institute offers a catalog of over 200 programs for pharmaceutical, medical device, and clinical research professionals. Below is our list of ISO 13485:2016 training courses and professional certification programs:


Certification Training ISO 13485:2016 Professional Certification Program
Professional Certification Program:

ISO 13485:2016 Professional Certification Program

Course ID: ISOPCRT
Price: $1295 | Learn More

Certification Training ISO 13485:2016 - Chapter 1-3: Introduction
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 1-3: Introduction

Course ID: ELM-801
Price: $199 | Learn More

Certification Training ISO 13485:2016 - Chapter 4: The Quality Management System (QMS)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)

Course ID: ELM-802
Price: $199 | Learn More

Certification Training ISO 13485:2016 - Chapter 5: Management Responsibility
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 5: Management Responsibility

Course ID: ELM-803
Price: $199 | Learn More

Certification Training ISO 13485:2016 - Chapter 6: Resource Management
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 6: Resource Management

Course ID: ELM-804
Price: $199 | Learn More

Certification Training ISO 13485:2016 - Product Realization (Chapter 7 - Part A)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Product Realization (Chapter 7 – Part A)

Course ID: ELM-805
Price: $199 | Learn More

Certification Training ISO 13485:2016 - Product Realization (Chapter 7 - Part B)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Product Realization (Chapter 7 – Part B)

Course ID: ELM-806
Price: $199 | Learn More

Certification Training ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)

Course ID: ELM-807
Price: $199 | Learn More

Certification Training ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part B)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)

Course ID: ELM-808
Price: $199 | Learn More

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 training reimbursement policy.
  • 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.