A device change to assess? Impact analysis in minutes, not weeks.
Marketing wants to change a claim, R&D a component, purchasing a supplier. Describe the change to My Audit Corner: it assesses the regulatory impact on your requirements and on all your existing documents, and tells you whether the change is substantial or significant, with the reasoning behind it.
The analysis, the committee note and the PDF record, in the same exchange.
Why every change takes weeks
A change looks simple from marketing. From regulatory, it often touches far more than expected.
Everything has to be gathered before deciding
Technical file, risk management, clinical evaluation, labelling: the information is scattered across departments, and pulling it together takes weeks.
The qualification has consequences
Substantial, significant or not: the answer decides whether the Notified Body must be notified. Getting it wrong one way costs time, the other way a non-conformity.
The same questions keep coming back
With every request, regulatory redoes the same analysis and re-explains the same constraints, while the project waits.
The same change, without and with My Audit Corner
| Step | Without the tool | With My Audit Corner |
|---|---|---|
| Describe the change | An email, then a meeting, then another | The requester describes the change in the chat and links it to the device |
| Assess the impact | Collect information department by department | Impact assessed across all requirements and all existing documents |
| Qualify | Experts debating substantial versus significant | A reasoned rationale, according to the applicable case |
| Adjust | Start over if the project evolves | Narrow, broaden or adjust the change while seeing the effort involved |
| Decide and record | Write the committee note and the record by hand | Departments involved identified, committee note drafted, PDF export for the change management required by ISO 13485 |
Describe the change
Without the tool
An email, then a meeting, then another
With My Audit Corner
The requester describes the change in the chat and links it to the device
Assess the impact
Without the tool
Collect information department by department
With My Audit Corner
Impact assessed across all requirements and all existing documents
Qualify
Without the tool
Experts debating substantial versus significant
With My Audit Corner
A reasoned rationale, according to the applicable case
Adjust
Without the tool
Start over if the project evolves
With My Audit Corner
Narrow, broaden or adjust the change while seeing the effort involved
Decide and record
Without the tool
Write the committee note and the record by hand
With My Audit Corner
Departments involved identified, committee note drafted, PDF export for the change management required by ISO 13485
The decision stays with your committee. MAC gives it in minutes what used to take weeks to gather.
Two ways to move forward
With the tool, by your team
The Change Impact Analysis module is open to every department, not just regulatory. Anyone can test a change before proposing it.
With our experts, at a fixed price
For a structural change, a new market or a new indication, our experts build the complete regulatory strategy.
Frequently asked questions
Any department: marketing, R&D, purchasing, production. The requester describes the change in plain language, without needing regulatory vocabulary.
It produces a reasoned rationale according to the applicable case, based on your documents and the requirements. The final decision rests with your committee, which then has everything it needs.
The impact analysis, the qualification of the change and its rationale, and the documents and departments concerned. It serves as a record in your change control process.
It is the same mechanism, triggered by the regulatory watch: MAC measures the impact of the change in the standard on each of your devices.
The next change is already in the pipeline.
Describe it to MAC: the impact, the qualification and the committee note, in a few minutes.