Definitive Guide to Manufacturing MDR Regulated Custom-made medical devices at the Point of Care
Additive manufacturing at the Point of Care has been around for some years now. Hundreds of hospitals around the world are now benefiting from desktop, affordable yet capable 3D printing devices that enables them to produce a range of medical devices from anatomical models to implants!
In order to continue using their additive manufacturing capabilities to provide bespoke services to their patients, health institutions have to be able to perform the regulatory tasks of medical device manufacturers. With the MDR on the horizon for implementation in May 2021, a lot of questions have remained unanswered:
What are the differences between EU MDR and MDD’s approach to custom-made medical devices?
Which devices are considered custom-made? Are all 3D printed devices custom-made medical devices?
Who is the legal manufacturer?
What can health institutions do with devices manufactured at the point-of-care?
What documents are needed to be prepared for auditors?
Is a Quality Management System (QMS) necessary? Does it have to be ISO 13485?
How to make sure that every device is a regulated device under MDR guidelines?
And tens of more questions!
Thus we decided to share our in-depth knowledge with our fellow industry experts and create a definitive guideline on reading and understanding EU-MDR’s position on manufacturing custom-made medical devices at the point of care.
You can download this E-book and confidently refer to it whenever you have a question about point of care manufacturing, custom-made devices, and EU MDR.
Or, you can schedule a call with us to discuss how Fusedbone can accelerate your journey to become a fully compliant and a leading 3D Printing Lab at the Point of Care.