Ensure Regulatory Compliance for 3D Printing at Point-of-Care (PoC)
In-house manufacturing of medical devices, including those created using 3D printing, offers hospitals incredible opportunities to personalize patient care. However, the European Medical Device Regulation (MDR) imposes strict requirements on healthcare institutions that manufacture devices internally. According to MDR Article 5.5, hospitals must ensure full compliance, including the implementation of an appropriate Quality Management System (QMS). Hospitals are subject to regulatory body audits, and if an audit identifies non-compliance, they are considered legally in default and may face substantial fines, since patient safety is at risk.
Why is a QMS Essential?
Under MDR, an effective QMS is the cornerstone of compliance for point-of-care manufacturing. It encompasses far more than just segmentation, design, and 3D printing instructions. A QMS addresses every stage of the device lifecycle, from purchasing raw materials, to design and validation to risk management, post-market surveillance, and reporting. It ensures that every device manufactured is safe, effective, and meets the rigorous standards set by MDR.
Our Simplified Approach to QMS Implementation
Implementing a QMS tailored to 3D printing at PoC can feel overwhelming. That’s where Qase3D comes in. I offer a complete set of documented procedures necessary for establishing a compliant QMS, based on ISO 13485. These serve as a flexible framework that must be customized to align with each client’s specific requirements. My approach is best described as a guided DIY method: you take the primary role in implementing the QMS, with my ongoing support as a consultant to provide advice and answer questions, ensuring your success throughout the process. This Quality BluePrint 5D method streamlines the process, making it achievable without sacrificing compliance or quality. Using an affordable, flexible platform, we build a comprehensive QMS that is:
- Cost-effective: Avoid the high costs of dedicated QMS software.
- Flexible: Adapt the system to meet your hospital’s unique needs.
- Versatile: Use the platform not only for compliance but also as a knowledge base.
- User-friendly: Ensure staff can navigate and maintain the system easily.
More Than a Requirement – A Guarantee for Safety and Efficacy
An easy-to-use QMS isn’t just about ticking regulatory boxes; it’s a tool that helps guarantee the safety and efficacy of your medical devices. With a properly implemented QMS, you can:
- Ensure traceability and accountability.
- Mitigate risks and respond to potential issues effectively.
- Build confidence among surgeons, patients and regulatory bodies.
Ready to Simplify Compliance?
Our tailored QMS method makes compliance achievable, though it’s important to acknowledge that building a robust system requires commitment and effort. Learn more about our method and take the first step toward securing your institution’s compliance and reputation.