When you start setting up a 3D lab (in a hospital), you are faced with many choices and decisions in terms of facility space, infrastructure (software+hardware), human resources, post-processing, etc. Some requirements you may not even consider upfront.
Typical questions that arise:
🔹 What 3D printers do you need?
🔹 Which software and materials?
🔹 What to print and what to outsource?
🔹 What infrastructure, tools and disposables are needed?
🔹 What kind of ventilation is necessary?
🔹 Who is an ISO 13485 certified partner?
🔹 How to clean and sterilize your parts?
🔹 How to train your engineer?
🔹 How to manage Quality?
🔹 How do I validate my software, materials and processes?
🔹 And many more…
Be especially 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.
Please know that certified software or certified materials has limited value, unless you validate!
And you do need an appropriate Quality Management System (QMS) according to comply with MDR article 5.5.
❗ Note that you don’t always need the most expensive tools to deliver high quality patient-matched devices.
I can help you with all these questions. Book a meeting to discuss your needs: