Setting up a 3D (printing) lab at Point-of-Care?
Looking to produce patient-matched anatomical models, surgical guides or even custom-made implants?
With over 15 years of experience in medical 3D printing, I am familiar with all the (medical) 3D printing technologies, (most) 3D software packages and trustworthy 3D printing partners. Let Qase3D help you in setting up your 3D printing lab or 3D printing at Point-of-Care (PoC) in your hospital.
- What 3D printers do you need?
- Which software and materials?
- What to print and what to outsource?
- What infrastructure and tools are needed?
- Who is an ISO 13485 certified partner?
- How to clean and sterilize your parts?
- How to train your engineer?
- How to manage Quality?
Compliance and Quality at Point-of-Care
Be aware of the risks of producing medical devices! Low risk devices you can design and produce in-house. I would advise to work with an ISO 13485 certified manufacturing partner for higher risk devices.
Note that you don’t always need the most expensive tools to deliver high quality patient-matched devices. But you do need an appropriate Quality Management System (QMS) according to comply with MDR article 5.5. And certified software or materials has no value, unless you validate!
From hands-on experience I know about the regulatory requirements (MDR) around custom-made devices (MDR Annex XIII) and In-Hospital-Produced devices (MDR art. 5.5) and I can help to achieve MDR compliance and implement an easy-to-use digital Quality Management System (based on ISO13485) to safeguard the Quality of your medical devices.