Certificate in Health-Tech Product Lifecycle Management Fundamentals
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• Product Ideation & Concept Development: This unit covers the process of generating and validating health-tech product ideas, including user research, market analysis, and prototyping.
• Regulatory Affairs & Compliance: This unit explores the regulatory landscape for health-tech products, including FDA approval processes, quality management systems, and data privacy regulations.
• Design Controls & Risk Management: This unit covers design controls, a systematic set of activities to ensure that a product is designed to meet user needs, and risk management, a process to identify, assess, and mitigate potential risks associated with the product.
• Clinical Trials & Data Management: This unit covers the planning, execution, and analysis of clinical trials, including data management, statistical analysis, and reporting.
• Manufacturing & Supply Chain Management: This unit covers the processes involved in manufacturing health-tech products, including supply chain management, inventory control, and quality assurance.
• Software Development & Integration: This unit covers software development for health-tech products, including software design, coding, testing, and integration with other systems.
• Verification & Validation: This unit covers the processes involved in verifying and validating health-tech products, including design verification, performance testing, and usability testing.
• Post-Market Surveillance & Continuous Improvement: This unit covers post-market surveillance, including monitoring and reporting adverse events, and continuous improvement, including product updates and enhancements.
• Stakeholder Communication & Project Management: This unit covers effective communication with stakeholders, including team members, investors, regulators, and users, and project management best practices.
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Zugangsvoraussetzungen
- Grundlegendes Verständnis des Themas
- Englischkenntnisse
- Computer- und Internetzugang
- Grundlegende Computerkenntnisse
- Engagement, den Kurs abzuschließen
Keine vorherigen formalen Qualifikationen erforderlich. Kurs für Zugänglichkeit konzipiert.
Kursstatus
Dieser Kurs vermittelt praktisches Wissen und Fähigkeiten für die berufliche Entwicklung. Er ist:
- Nicht von einer anerkannten Stelle akkreditiert
- Nicht von einer autorisierten Institution reguliert
- Ergänzend zu formalen Qualifikationen
Sie erhalten ein Abschlusszertifikat nach erfolgreichem Abschluss des Kurses.
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