Medical devicesChange control

Approve the change once.Every record it touches follows.

The DMR, risk file, validation and training update on one record, with the 510(k) call and every sign-off.

The six records the change moves, linked on CC-2148 with an owner each

Built to the frame you are inspected against

  • 21 CFR 820 (QMSR)
  • ISO 13485:2016
  • ISO 14971
  • 21 CFR Part 11
  • 21 CFR 807.81 · 510(k)

The change is approved. Its records are not.

Between PLM and the QMS, the change board runs on a spreadsheet and email.

Approved at the board on Sep 12. The contract sterilizer ran the next lot on Rev C.
  1. The 510(k) call lives in a memo.The change never links to why.
  2. The DMR, risk file and label update apart.Three systems, no cross-reference.
  3. The sterilizer hears by email.Its acknowledgement sits in an inbox.
  4. Nobody confirms it landed.Each site goes live on its own date.

A typical device ECO: 12 people, 8 sign-offs, 14 pieces of evidence, 5 systems and months at risk. That overhead is the coordination tax.

Measure your coordination tax →

Run the change on one record, from the CAPA to the last site.

Each owner does their part on the change itself, so the reasoning is on the record before anyone signs it.

What the investigator asks for is already on the record.

Under the QMSR, 21 CFR 820 incorporates ISO 13485. These are the questions a change gets asked at inspection, answered where CC-2148 already holds them.

  1. 21 CFR 807.81(a)(3)

    Did it need a new 510(k)?

    No. R. Kapoor's assessment and the reasoning sit on the change, not in a memo.

  2. ISO 13485 4.2.4

    Which revision was in use, and where?

    Rev D, effective at Line 2 and the contract sterilizer on the same day. Rev C retired.

  3. 21 CFR Part 11

    Who approved it, and what did they mean?

    Three signatures on the change itself, each with the name, the meaning and the time.

When a change becomes the finding.

Each of these turns on a change like CC-2148. On the record the answer is a lookup, not a reconstruction.

DHF gap at audit

Routes to Design Controls & Traceability · owned by Engineering · Regulatory · Quality

A site on the superseded revision

Routes to Document Control · owned by Document Control · Quality

Training behind an effective change

Routes to Training Management · owned by Training Coordinator · Quality

Device teams already run change this way.

Engineering and quality at a surgical robotics maker, on what changed once the review, the approvers and the release lived on one record.

All customer stories
Change control for medical devices

Bring one real ECO.

A stalled design change or a supplier-driven one. See it run as one record, 510(k) call included, in a 30-minute walkthrough.