ISO 14155 Certified Auditor Training | Clinical Investigation Of Medical Devices For Human Subjects скачать в хорошем качестве

ISO 14155 Certified Auditor Training | Clinical Investigation Of Medical Devices For Human Subjects

ISO 14155 Overview 1. Title: Clinical investigation of medical devices for human subjects — Good clinical practice 2. Published: 2019 (latest version) 3. Replaces: ISO 14155:2011 Scope 1. Applies to clinical investigations of medical devices 2. Covers good clinical practice (GCP) principles 3. Ensures protection of human subjects and data integrity Key Principles 1. Risk-based approach: Focus on potential risks and benefits 2. Protection of human subjects: Prioritize subject safety and well-being 3. Data quality and integrity: Ensure accurate, complete, and reliable data 4. Transparency and accountability: Promote transparency and accountability throughout the clinical investigation process Benefits 1. Improved patient safety: Enhanced protection of human subjects 2. Increased data quality: More reliable and accurate data 3. Regulatory compliance: Compliance with regulatory requirements 4. Competitive advantage: Demonstrate commitment to quality and safety Implementation 1. Gap analysis: Identify areas for improvement 2. Develop quality management system: Establish a QMS that meets ISO 14155 requirements 3. Train personnel: Educate personnel on ISO 14155 principles and requirements 4. Conduct internal audits: Regularly assess compliance with ISO 14155 5. Obtain certification: Consider certification from a recognized certification body Tools and Resources 1. ISO 14155 standard: Obtain a copy of the standard from ISO 2. Guidance documents: Consult guidance from regulatory agencies and industry associations 3. Templates and checklists: Utilize templates and checklists for clinical investigation planning and conduct 4. Training courses: Participate in training courses and workshops on ISO 14155 5. Consultants and experts: Engage consultants and experts with ISO 14155 experience #ISO14155 #ClinicalInvestigations #MedicalDeviceRegulations #GoodClinicalPractice #GCPTraining