Visit our Quality page to learn more about the ISO 13485:2016 certification of BellaSeno's quality management system.
ISO 13485-compliant Additive Manufacturing of Medical Devices
BellaMake by BellaSeno offers ISO 13485-compliant CMO services within an ISO Class 7 cleanroom from small batch production for preclinical testing, production units for clinical trials as well as series production at commercial scale.
Small Scale Production
When creating a novel 3D-printed medical device, processes are typically developed at laboratory scale. These laboratory scale production processes may be sufficient for early performance, ISO 10993 biocompatibility studies in animals and related pre-clinical work.
BellaSeno can engineer your process to manufacture these batches as close to final manufacturing parameters as possible to ensure the results from these early studies can reliably be used for regulatory submissions.
As you proceed to clinical trial studies, your production needs will increase.
BellaSeno can scale up your Additive Manufacturing processes from laboratory to industrial scale in a cost-effective and ISO 13485-compliant manner ensuring that your critical quality attributes are unchanged in the resulting scalable process.
Project Development Pathway
We understand the importance of communication with our clients and therefore schedule meetings regularly to remain fully aligned with you throughout all phases of a project.
The BellaMake project team consists at least of the following roles:
- Project Leader: Ensures the correct management of the project internally at BellaSeno and is your main contact person.
- Manufacturing Lead: Responsible for day-to-day manufacturing
Quality Assurance (QA) Lead: Responsible for the quality assurance and audits during the project
Why Work With Us:
- Reduction of start-up costs.
- Access to BellaSeno’s specialised design software and Additive Manufacturing equipment.
- Access to technical and regulatory expertise.
- Accelerate time to market.
Contact us to discuss your contract manufacturing requirements.