Medical devices
The batch record is in a file, the complaint is in an email, and the auditor wants both by Thursday. We build software that keeps the record as the work happens.
Genbays builds custom software for medical device makers and their distributors: batch and device history records captured as the work happens, complaints and service calls with a trail, distributor orders and stock from one record, and audit packs that come out of the system.
Built in from day one
- Records kept for the retention your standard asks for, with a change trail
- Access by role, and a log of who changed what and when
- Works alongside the quality management system you already run
What's slow, and what we build
What's slow
Batch, calibration, complaint and service records kept on paper and in spreadsheets, pulled together by hand whenever an auditor, a regulator or a distributor asks. Distributor orders and stock tracked over the phone.
What we build
Records captured as the work happens, with a named trail an auditor can follow, so the pack comes out of the system. Complaints and service calls logged once and tracked to close, with the device and the customer attached. Distributor orders, stock and invoices from one record.
Workflows we usually start with
01
Batch and device history records
Every batch with its record, signed and dated as it happens.
02
Complaints and service calls
Logged once, tracked to close, with the device and the customer attached.
03
Distributor orders and stock
Orders, stock by location and invoices from one record.
04
Audit and regulator requests
The pack assembled from records that already exist.
Questions people ask us
Do you know ISO 13485 and the Indian medical device rules?
We learn your standard with you in Study and build the controls it asks for: signed records, retention, a change trail. Your quality lead stays in charge of what the standard means. We make the record easy to keep.
Our quality system is on paper and audited that way.
It can stay on paper where the auditor expects it, and be born in the system where that's faster. Most makers move one record type at a time.
Can distributors see stock?
If you want them to, with a private view of their own orders and nothing else.
Tell us how work moves in your medical devices business.
Forty-five minutes, no charge, no pushy follow-up. You'll talk to someone who builds software, not someone who sells it. You keep the workflow map either way.