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

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

Certification TrainingProgram/Course ID: ELM-806
Enrollment Period: 3 months.
Allocated Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $199.00

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

Training 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 within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


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).

ISO 13485:2016 - Product Realization (Chapter 7 - Part B) is Included in the Following Professional Certification Program(s):

 Professional Certification Program: 
ISO 13485:2016 Professional Certification Program
Price: $1295.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.

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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