The technical file cites an old edition
A procedure still names the edition that was current at the last audit, not the one published since.
Medical devices
ISO 13485 software for the standards your device file cites
A medical device quality system lives or dies by the editions named in the procedures. SCM Checker watches those designations and tells the owner when status, edition, or amendments change.
For quality and regulatory teams at device manufacturers
ISO 13485 is the quality system. Around it sit ISO 14971 and the other ISO and EN designations named in the technical file. Those citations go stale when nobody is assigned to check them.
Amendments never reach the device record
A notice lands in one inbox and never gets written back onto the controlled list.
Suppliers and the plant disagree
Purchasing buys to one designation while quality still has the previous one on the register.
What SCM Checker does
ISO 13485 and the standards around it
Add ISO 13485, ISO 14971, and the other ISO, EN, and ANSI designations your file actually cites.
An owner for each citation
The person accountable for that designation gets the alert, not a shared regulatory inbox.
A list you can show an auditor
Status, edition, notes, and review dates stay on the record for the next surveillance visit.
Questions
Is SCM Checker a replacement for our ISO 13485 quality system?
No. Your procedures, device records, and registrar stay as they are. SCM Checker keeps the list of cited standards current so the quality system is not working from a withdrawn edition.
Does it include the text of ISO 13485?
No. SCM Checker shows designation, status, edition, and dates. You still obtain the official standard from the publisher.
Can we track more than ISO 13485?
Yes. Add the other ISO and EN designations named in your procedures, and ANSI designations on the Growth plan. Assign an owner to each one.