Additive manufacturing in regulated medtech environments comes with different demands than in general industry. leanAM MES provides the infrastructure for an AM production that can be audited and whose data never leaves the company network.
Regulatory requirements and best practice call for complete documentation of who printed what, when, with which material and which parameters. leanAM MES logs every job in an audit-proof way.
CAD geometries, process parameters and production data never leave the company network. On-premise installation on your own infrastructure, no cloud connection required.
Approval workflows, role concepts and four-eyes principle for print releases. The system governs who may start a job and who has to check it beforehand.
Every batch, every spool, every material is tied to a print job. Indispensable for recall scenarios and audit requirements.
Every action in the system is logged with a timestamp and user. The logs are immutable and exportable, ready for internal and external audits.
leanAM MES runs entirely on the intranet. Printers and servers can be operated disconnected from the internet, which matters for safety-critical production environments.
Three fields where additive manufacturing already pays off, without the regulatory effort of patient contact.
Fast iteration of housings, mounts, grip geometries and functional models without patient contact. This is where AM is most widespread and immediately economical.
Assembly fixtures, calibration holders and inspection gauges can be tailored to a product line and produced cheaply. No patient contact, low regulatory effort.
Patient-specific planning models from CT/MRI data for surgical preparation and training. Clear medical value, no direct patient contact.
Patient-specific implants made by AM require ISO 13485 certification, biocompatibility evidence (ISO 10993) and MDR conformity assessment. That is a regulatory project in its own right. leanAM supports it, but the certification path stays with the company.
Production data in medical technology — geometries, parameter sets and material batches — is business-critical and in part personal data (patient-specific parts). Cloud services with servers outside the EU do not meet GDPR requirements without considerable additional effort.
leanAM MES runs on your server in your network. The data stays within the company, and updates happen on your schedule.
leanAM MES provides traceability, auditable logs and local data storage: building blocks for processes that support MDR requirements. System conformity remains the responsibility of the user company.
Cloud software sends production data to external servers. In medical technology this is often sensitive geometries and proprietary designs. The GDPR and regulatory requirements call for local data storage in many cases.
leanAM MES supports several ways of controlling printers directly on the local network, without an external cloud and without a mandatory account. Print data stays entirely within your infrastructure. Whether and to what extent your production environment can be supported is something we can review in a conversation. Feel free to get in touch with us.
Regulatory requirements, machine selection and MES integration are best clarified against your specific use case, in a conversation with no strings attached.
