Case Management in Patient-Specific Surgical Planning, Surgical Guides, and Custom-Made Implants
Case management plays a vital role in the production and implementation of 3D-printed patient-specific surgical planning, surgical guides, and custom-made implants. Not only does it ensure streamlined operations, but it also helps achieve traceability—a fundamental requirement of a Quality Management System (QMS) under ISO 13485.
Why is Case Management Important?
Traceability is critical for ensuring the safety and efficacy of patient-specific devices. Proper case management enables you to:
- Track every step of a patient’s case, from initial assessment to final delivery.
- Maintain detailed records of design iterations, materials used, and manufacturing processes.
- Comply with regulatory requirements and be prepared for audits.
While case management is essential for traceability, it’s important to recognize that a QMS extends far beyond this scope. For a comprehensive overview of QMS requirements, visit https://qase3d.com/iso13485/.
Options for Case Management Platforms
Hospitals and organizations working with 3D-printed medical devices have several options for implementing effective case management systems:
- Dedicated Case Management Platforms
- There are specialized platforms designed specifically for medical case management. These systems often come with features tailored to patient-specific workflows and regulatory compliance.
- I am familiar with various providers and can assist you in identifying the most suitable platform for your needs.
- Building on Existing Project Management Platforms
- Alternatively, case management systems can be created within widely used project management platforms. These platforms are often more affordable, highly customizable, and versatile, serving as both a case management tool and a knowledge base.
- I can guide you through the process of setting up a case management system in such a platform, ensuring it meets regulatory requirements while remaining user-friendly.
How I Can Help
Whether you choose to license a dedicated platform or build a system within an existing tool, I provide the expertise needed to implement an effective case management solution.