Design change traceability for medical devices
In short
Design change traceability means that every change to a device design can be followed from the change request through requirements, CAD revisions and drawings to the risk management file, with review and approval on record. We set up these links in your PDM, so each change carries its own evidence.
Updated 27 Oct 2026
A dimension on an implant changes after a complaint. The auditor asks which requirement it serves, which risk control it touches, who approved it and which drawings and parts changed with it. When the answers sit in emails and file names, finding them means searching folders and inboxes.
- Start with
- Intro callfree, 45 minutes
- Billing
- Day rates€790 engineer day · €990 lead day
- Systems
- Solid Edge, SolidWorks, Inventor, SolidWorks PDM, Autodesk Vault, 3DEXPERIENCE
How it works
- 01
Trace today's change path
We follow how a design change runs today, from the change request through CAD, drawing, BOM and risk documentation to release, and note where links are missing.
- 02
Define the links
Requirement to CAD part, part to drawing, change request to affected revisions, change to the entry in the risk management file. Your quality management decides which records are required.
- 03
Set up the PDM workflow
The change workflow in SolidWorks PDM, Vault or 3DEXPERIENCE carries the change request, the affected items and the approvals, and freezes revisions at release.
- 04
Check before release
An automated check lists open links before approval, for example a changed part without an updated drawing or a change without impact assessment. Work is billed as a day rate per engineer, on tasks agreed with our project lead.
What you get
Traceability model
Documented links between requirements, CAD revisions, drawings, change requests and risk file entries, with an owner for each.
Configured change workflow
Change process in your PDM with affected items, review and approval steps and frozen revisions.
Pre-release check
A list of missing links and open approvals for every change, each finding with the rule it breaks.
Trace report per change
One view per change: what changed, why, who approved it and which records belong to it, ready for design review and audit.
Limits
Traceability links records; it does not judge whether a change is safe or whether it needs a new regulatory submission. That stays with your engineers, risk management and regulatory affairs; this page is not legal or regulatory advice. Requirements and risk files kept in Word or Excel can be linked, but checked in depth only once they are structured. Existing products are usually linked from their next change onwards, not retrospectively.
Systems
- Solid Edge
- SolidWorks
- Inventor
- SolidWorks PDM
- Autodesk Vault
- 3DEXPERIENCE
Frequently asked questions
What is design change traceability in medical device development?
Design change traceability means each change to a device design can be followed back to its reason and forward to every affected requirement, model, drawing, risk control and verification record. It answers what changed, why, who approved it and what was checked. In practice it relies on stable IDs and links between the PDM, the requirements and the risk management file.
What does ISO 13485 require for design changes of medical devices?
ISO 13485:2016 clause 7.3.9 requires design and development changes to be identified, reviewed, verified or validated as appropriate, and approved before they are implemented. Their effect on the device, its parts and the risk management has to be evaluated, and records are kept. Clause 7.3.10 requires a design and development file per device type or family that contains or references these records.
Can SolidWorks PDM or Autodesk Vault link CAD revisions to change requests?
Yes. In SolidWorks PDM, change requests are usually set up as their own documents with a data card and a workflow that reference the affected files. Vault Professional has change orders that list affected files and items and route them through review and approval. Requirements or risk files kept outside the PDM are linked through reference fields or an interface.
Requirements management tool vs. PDM: where should medical device design traceability live?
Usually in both, with a clear split. Requirements, verification and risk controls are often kept in a requirements or ALM tool or in controlled documents; CAD models, drawings and revisions live in the PDM. Traceability works when each side holds a stable ID of the other and a change on one side shows up on the other. Copying requirements into the PDM creates two versions of the truth.
Talk to us about your task.
In the free 45-minute intro call we show a live demo on comparable geometry. Someone from our team replies personally within one working day.