QasE3D offers various Quality Management Systems (QMS), specifically for custom-made and/or 3D printed medical devices.
Which one you need depends on your business model:
| Company type | Recommended Management System | Remarks |
|---|---|---|
| Medical Device company Your company makes and sells medical devices under your own brand |  ISO 13485 QMS | A complete digital QMS including all requirements from ISO 13485 for medical device manufacturers |
| 3D printing company Your company 3D prints parts as a supplier for hospitals |  ISO 13485 QMS Light* | A reduced digital QMS including only the core requirements from ISO 13485 |
| Large Point-of-Care 3D lab Your lab produces medical devices for your own and other hospitals (and potentially spins-out at some point). |  ISO 13485 QMS Light* | A reduced digital QMS including only the core requirements from ISO 13485 |
| Point-of-Care 3D lab Your lab produces medical devices and needs to be MDR compliant |  MDR Management System | A complete management system including all requirements from the MDR for custom-made device manufacturers |
*) The ISO 13485 Light QMS can later be extended to a full ISO 13485 QMS, in case you want to get certified.
How is the MDR Management System different from the ISO 13485 Light for PoC?The MDR Management System focuses on the (minimum) regulatory requirements of the MDR — practical, lean, and tailored for Point-of-Care 3D printing. The ISO 13485 Light quality system is a reduced QMS for medical device manufacturers, covering the core requirements of this quality standard. You minimally need the MDR Management System to be compliant and you can combine it with ISO 13485 (Light) if you want to achieve ISO 13485 certification.