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 with 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 with only the core requirements from ISO 13485 |
| Small Point-of-Care 3D lab Your lab produces medical devices only within your hospital | 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.