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ISO 13845 FDA Medical Device Regulation For QMS (Part 2 / 2)


Learn all about ISO 13845 FDA Medical Device Regulation and Quality Management System in this online course

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What you'll learn

  • Importance of product safety and risk control measures in the complex design and development process for medical devices
  • Systematic reviews and stages involved in ensuring the success of the design and development process.
  • Critical role of planning in design and development, including goal identification and resource planning.
  • Key documentation requirements and the need for consistency with the organization's QMS.
  • Understanding and defining design inputs, including customer expectations.
  • Overview of design outputs and the importance of reviewing and approving them.
  • Procedures and importance of transferring design outputs to manufacturing.
  • Managing changes in design and development, including risk assessment and maintaining design history files.
  • Significance of design review stages, addressing concerns, and involving independent reviewers.
  • Processes and methods for design verification and validation to ensure compliance with specified requirements.
  • Understanding ISO 13485 regulations related to purchasing and evaluating risks associated with outsourced products and services.
  • Steps in the purchasing process, including supplier selection, qualification, and monitoring.
  • Defining purchasing information and its role in communicating requirements to suppliers.
  • Importance of clear communication, written quality agreements, and establishing necessary purchasing requirements.
  • Implementing verification activities for purchased products based on supplier evaluation results.
  • Ensuring purchased products meet specified requirements and conform to QMS standards.
  • Recognizing different types of products and services provided by suppliers.
  • Understanding the significance of supplier risk assessment and control measures.
  • Importance of controls for product quality and regulatory compliance.
  • Proportionality of controls based on process criticality determined through risk management.
  • Six controls during the production process
  • Choosing buildings, workspaces, and equipment for production.
  • Verification of new or modified equipment to ensure effectiveness.
  • Monitoring production for consistency and adherence to controls.
  • Specific controls for minimizing packaging and labeling errors.
  • Establishment and maintenance of records for each medical device or batch.
  • Batch record or Device History Record (DHR) contents.
  • Requirements for electronic batch records and software validation.
  • Demonstrating control over external providers in production.
  • Maintenance of batch records for external production activities.
  • Documentation of cleanliness requirements.
  • Cleaning procedures, resource allocation, and verification/validation activities.
  • Documentation and acceptance criteria for medical device installation.
  • Final testing after installation and connection to infrastructure.
  • User instructions for device assembly, installation, and safety controls.
  • Quality management system inclusion of installation requirements.
  • Requirements for servicing medical devices.
  • Documentation of servicing procedures, planning, and validation.
  • Training and competence of servicing personnel.
  • Analysis of servicing records for improvements.
  • Records and traceability for sterilization processes.
  • Sterile barrier system maintenance and validation.
  • Considerations for microbiological status of raw materials and manufacturing environment.
  • Definition and importance of process validation.
  • Documentation of process validation procedures, criteria, and software validation.
  • Three-step process validation and associated activities.
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Identification, verification, protection, and safeguarding of customer property.
  • Protection of confidential health information.
  • Measures to protect intellectual property and personal data.
  • Requirements for preserving medical devices throughout their life cycles.
  • Documentation of preservation procedures during processing, storage, handling, and distribution.
  • Considerations for environmental conditions during transportation and storage.
  • Calibration requirements for monitoring and measuring equipment.
  • Procedures for equipment calibration, adjustment, and protection.
  • Software validation for monitoring and measuring equipment.
  • Importance of maintaining records for calibration and verification activities.
  • Identification of processes and resources aligned with business goals.
  • Definition of requirements for data sources, including limits and acceptance criteria.
  • Review of critical processes for quality and regulatory requirements.
  • Periodic management reviews to ensure suitability and effectiveness.
  • Steps for addressing potential complaints, including investigation and reporting.
  • Importance of segregating and disposing of returned or faulty products.
  • Analysis of complaint records for updating risk management plans.
  • Procedures for reporting complaints to regulatory authorities and issuing advisory notices.
  • Determination of significance, segregation, and documentation of nonconforming products.
  • Actions required for different types of nonconformities, including scrapping or destruction.
  • Procedures for product recall, including advisory notice contents.
  • Measures for preventing reoccurrence and providing corrective actions.
  • Creation of documented procedures for data analysis during the QMS planning stage.
  • Use of statistical and non-statistical methods for identifying nonconformities.
  • Application of statistical techniques like Pareto analysis and SPC charts.
  • Importance of analyses at various organizational levels and across different data sources. Section 12 Vide
  • Documentation and steps involved in CAPA activities.
  • Tools for identifying problems: Cause and effect diagrams, 5 Whys analysis, etc.
  • Importance of validation activities to confirm the effectiveness of corrective actions.
  • Criteria for determining the effectiveness of corrective actions.


  • This course is designed for individuals from diverse backgrounds, and no specific prerequisites are needed. Whether you're new to the field or an experienced professional, this course caters to a broad audience.
  • ISO 13845 FDA Medical Device Regulation For QMS (Part 1 / 2)

Unlock Excellence in Medical Devices: Mastering ISO 13485:2016 Online Course

Welcome to the definitive online course on ISO 13485:2016, your gateway to unparalleled expertise in the quality management system for medical devices. This comprehensive program is meticulously crafted to empower professionals like you, ensuring you not only understand but master the intricacies of ISO 13485:2016.

What Sets This Course Apart:

Expert-Led Learning: Delve into the world of ISO 13485:2016 with our seasoned industry experts who bring real-world experience to your virtual classroom. Benefit from their insights, case studies, and practical tips that go beyond textbook knowledge.

Interactive Modules: Say goodbye to passive learning. Our course is designed to keep you engaged through interactive modules, quizzes, and discussions. Dive deep into the nuances of ISO 13485:2016, ensuring you absorb and apply the information effectively.

Real-World Applications: We don't just teach theory; we guide you in applying ISO 13485:2016 to real-world scenarios. Gain the confidence to implement best practices, ensuring compliance and elevating the quality of medical device processes.

Resource Library: Access a treasure trove of resources, including downloadable templates, checklists, and reference materials. Our resource library is your go-to hub for practical tools that simplify the implementation of ISO 13485:2016 within your organization.

Community Support: Join a vibrant community of professionals who, like you, are committed to mastering ISO 13485:2016. Engage in discussions, share insights, and network with peers who understand the challenges and triumphs of navigating the medical device industry.

Why Enroll Today:

Invest in your professional development and take a significant step toward excellence in medical device quality management. By the end of this course, you'll not only be proficient in ISO 13485:2016 but also equipped to lead your organization to new heights of success.

Don't miss this opportunity to become a recognized authority in ISO 13485:2016. Enroll now and embark on a transformative journey toward mastering the standards that define the future of the medical device industry. Your success starts here!

Who this course is for:

  • Individuals involved in the creation or distribution of medical devices
  • Healthcare professionals
  • Regulatory affairs specialists
  • Quality assurance professionals
  • Medical device manufacturers

Courses to get you started -- > ISO 13845 FDA Medical Device Regulation For QMS (Part 2 / 2)