The released process, executed and recorded for every device.
Manual assembly of medical devices must follow the validated process every time, with a record for each unit. Arkite controls which instruction version is released, guides and validates each step, and records how every device was built.
What we hear from medical device manufacturers.
Every instruction change needs review and approval before it reaches the line.
Change control
Paper travelers are filled in after the fact, and the record is incomplete.
Records per unit
A missing or misplaced small component is invisible in the finished device.
Small, critical components
Only authorized people may change instructions, and operators must use the released version.
Controlled access
Four challenges in medical device assembly, and what changes with Arkite.
01Every instruction change reviewed and approved.
- Today
- Instruction updates must be reviewed and approved, and older versions must stay retrievable.
- With Arkite
- Jobs go through draft, review and production with a full version history. Only approvers release, and operators only see the released version.
02The defined procedure, followed step by step.
- Today
- It is hard to show that the procedure was followed step by step.
- With Arkite
- Instructions guide every step, and a 3D sensor checks each action and its order. The next step only starts after a correct action.
03Small components checked before the device is closed.
- Today
- Small components can be missing or misplaced without being visible in the finished device.
- With Arkite
- With Arkite VISION a camera checks components from 0.5 cm during assembly, before the next step. The detection runs locally.
04Reliable records per unit, without paperwork.
- Today
- Manual records are incomplete, and you need reliable data per unit.
- With Arkite
- Every step, check result, operator, time and torque value is stored per serial number, in your own database and available to your MES, ERP or quality system.
The topics that matter, and what Arkite does for each.
- Device history recordDHR and eDHR
Per-unit data passed to the system that holds the device history record, through a database connection, CSV or the Arkite API.
- Change control
Draft, Review and Production states, an optional approval workflow and a full version history.
- Audit trail
Every change to projects and settings recorded with user, timestamp, previous and new value, append-only and hash-chained.
- Controlled access
Users and roles from Active Directory. Operators have read-only access, and sensor data access is limited to dedicated roles.
Customer stories from regulated and quality-critical processes.
Related customer stories
Where medical device manufacturers use Arkite
Questions from medical device teams
Can Arkite be integrated into a production line in a controlled environment?
Arkite has been applied in a cleanroom application in the healthcare sector, integrated into the production line through PLC communication. The suitability of the workstation hardware for a specific environment is assessed per project.
Where is our production data stored?
On your own Arkite server, on premises or in your private cloud. The data remains fully owned by you. Optional AI features only send text to an external provider when you enable them with your own key.
Discuss your medical device process
Show us a manual process that must be controlled and recorded. We will walk through how Arkite would guide, validate and document it.
- A specialist replies to you personally
- We look at your process, products and systems
- Together we define a first pilot workstation