ISO 13485 FDA Medical Device Regulation For QMS (Part 1 / 2)

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

Created by: Magine Solutions Team
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What Will I Learn?

• Definitions of key terms in ISO standards: 'shall,' 'should,' 'may,' and 'can.'
• Understanding the mandatory, recommended, permitted, and possible requirements in ISO standards.
• Evaluation of medical device manufacturer's quality management systems.
• Emphasis on European medical device regulations and the Medical Device Single Audit Program (MDSAP).
• Understanding development, implementation, and maintenance requirements for medical device stakeholders.
• Focus on ISO 13485:2016, the most recent revision.
• Distinction between ISO level, European level, and national level standards.
• Introduction to harmonized standards and their adoption by European standardization organizations.
• Overview of ISO 13485's international scope and Z annexes related to European requirements.
• Understanding the Medical Device Single Audit Program (MDSAP).
• Purpose of MDSAP in preventing duplication of auditing efforts.
• Coverage of regulatory requirements for medical devices in Australia, Brazil, Canada, Japan, and the United States.
• Development and key players of the MDSAP.
• Importance of defining the scope of the Quality Management System (QMS).
• Factors to consider when determining the QMS scope.
• ISO 13485 Clause 4.1.6 requirements for validating computer software.
• Applicable software validation processes.
• Examples of software requiring validation.
• Requirements for documented QMS tailored to the organization's nature and purposes.
• Specific details and elements of QMS documentation.
• Examples of required QMS documentation.
• Importance of technical documentation in proving medical devices meet safety and performance requirements.
• Different terms for technical documentation.
• Requirements for medical device files (MDF) or technical files.
• ISO 13485 requirements for document and record control.
• Criteria for document control ensuring compliance and effectiveness.
• Lifetime determination of medical devices and handling of obsolete documents.
• Role of upper management in implementing QMS.
• Upper management's commitment, Quality Policy, Quality Objectives, and management reviews.
• QMS planning and maintaining integrity during changes.
• Defining and documenting responsibilities and positions of QMS-related personnel.
• Delegation of authority by upper management.
• Importance of good internal communication for QMS understanding.
• Elements evaluated by auditors during the management review.
• Data requirements for the management review process.
• Conducting a management review for an effective QMS.
• Understanding ISO 13485 requirements for resource management in the QMS.
• Evaluation of QMS-related resources: human resources, infrastructure, and work environment.
• Importance of competent employees and the risk-based approach in competency requirements.
• ISO 13485 requirements for proper infrastructure supporting QMS processes.
• Attention points during audits: buildings, equipment, and supporting services.
• Considerations for equipment design, installation, and maintenance.
• Regulation of the production environment for medical device quality.
• Methods to enhance safety and cleanliness in work environments.
• Parameters influencing controls for a safe work environment.
• Determining process inputs, outputs, sequence, and responsibilities in product realization.
• Requirements for quality objectives, resources, verification, monitoring, and records.
• Consistency with QMS requirements in product realization activities.
• Definition of "risk" and "risk management" in the context of medical devices.
• Risk management requirements for personnel, external providers, purchased products, and software validation.
• Role of risk assessments in reducing or controlling risk throughout the product realization process.
• Use of risk matrices to identify hazards and address safety requirements.
• Influence of risk management on various aspects of product realization.
• Involvement in customer-related processes, including receiving requirements and managing orders.
• Considerations for determining the safety of medical devices for customer use.
• Documentation of product requirements, regulatory requirements, and user training.
• Significance of labeling in customer communication.
• Requirements for physical labels and e-labeling.
• Critical role of labeling in preventing medical device recalls.

Requirements

• 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.

Target audience

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