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Home » ISO 13485:2016 - Product Realization (Chapter 7 - Part B)

ISO 13485:2016 - Product Realization (Chapter 7 - Part B) (ELM-806)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

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

Biopharma Institute LogoTraining Program: ISO 13485:2016 - Product Realization (Chapter 7 - Part B)
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThe primary part of the purchasing requirements for ISO 13485 is to ensure that purchased product conforms to specified purchasing information, which can essentially be broken down into three subsections, supplier selection and control, material specifications from qualified suppliers and verification of purchase product.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

ISO 13485:2016 - Product Realization (Chapter 7 - Part B) course is included in the following Professional Certification Programs:

ISO 13485:2016 Professional Certification: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Course Introduction
Course Objectives
CFR, ICH and The FDA
Challenges Facing the Medical Device Industry
Single User License

Product Realization - Part B
Purchasing Process - Conforms to Specified Purchasing Information
Purchasing Process - Key Areas
Purchasing Process - Analysis
Purchasing Process - Materials
Purchasing Information - Documented
Purchasing Information - Quality Agreement
Verification of Purchased Product - Inspection Process
Verification of Purchased Product - Labeling
Verification of Purchased Product - Inspection
Production and Service
Control of Production and Service Provisions
Cleanliness of Product - Work Environment & Sterile Products
Cleanliness of Product - Specific Requirements
Installation Activities
Installation Activities - Implantable
Servicing Activities
Servicing Activities Vs Complaints
Particular Requirements for Sterile Medical Devices
Validation of Processes for Production and Service Provisions - Intended Purpose
Validation of Processes for Production and Service Provisions - Validation Vs Qualification
Validation of Processes for Production and Service Provisions - IQ/OQ
Validation of Processes for Production and Service Provisions - PQ
Validation of Processes for Production and Service Provisions - Protocols
Validation of Processes for Production and Service Provisions - Lifecycle
Particulate Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems
Sterility Assurance Level (SAL)
Identification - Part Numbering System
Identification - General Rules
Identification - Easily Identified
Identification - Quality Unit
Traceability - Lot/Serial Numbers
Traceability - Few Common Mistakes
Traceability - Product Order Number
Traceability - Implantable
Customer Property
Preservation of Product - Procedures
Preservation of Product - Shipping
Preservation of Product - Environmental
Preservation of Product - Stability Studies
Preservation of Product - Accelerated Study
Preservation of Product - Closed/Open Containers
Control of Monitoring and Measuring Equipment
Control of Monitoring and Measuring Equipment - Inspection
Control of Monitoring and Measuring Equipment - Unique Number
Control of Monitoring and Measuring Equipment - ISO Standard
Control of Monitoring and Measuring Equipment - ISO 17025
Control of Monitoring and Measuring Equipment - Calibration
Control of Monitoring and Measuring Equipment - Software
Control of Monitoring and Measuring Equipment - Shutdowns


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of ISO 13485:2016 (Medical Devices).

Online Training: The Benefits of Remote Learning & 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.

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