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

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

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

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Program/Course ID:ELM-806
Enrollment Period:12 months.
Average Learning Time:~45 minutes.
Additional Resources:Supplemental materials/activities.
Accredited Program:0.1 CPD Credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Medical Device Regulatory Affairs.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training:Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $199.00 USD  
CPD Accredited Training

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

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 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 course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


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).

This Course is Included in the Following Professional Certification Program(s):

Professional Certification Program:

ISO 13485:2016 Professional Certification Program

Price: $1295.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.