PMS, PMCF, PSUR: what you promised, MAC checks it gets done.
To obtain CE marking, you committed to your Notified Body to carry out activities once the device is on the market. My Audit Corner finds these commitments in your documents, checks them against your records and tells you, activity by activity, what is overdue, what is coming up and what is up to date.
No re-keying: MAC takes the commitments from your own documents, where they already are.
The risk that grows once the device is certified
On the day of certification, everything is aligned. Then the device lives on, the team changes, and so do the priorities.
Commitments are scattered
PMS plan, PMCF plan, clinical evaluation, risk management: each document sets its own activities and its own frequency. Nobody has the full picture.
Tracking relies on a spreadsheet
When it exists, it is kept by hand, rarely up to date, and it does not tell you whether the expected record was actually produced.
The Notified Body does check
An activity promised and never carried out is a guaranteed non-conformity at the surveillance audit. It is also one of the most common findings, especially in SMEs.
The same follow-up, without and with My Audit Corner
| Step | Without the tool | With My Audit Corner |
|---|---|---|
| List the commitments | Re-read every plan by hand, document by document | Exhaustive reading of every document that sets post-market activities |
| Know the deadlines | Recalculate each frequency in a spreadsheet | The declared frequency (3 months, 6 months, 1 year, 3 years…) is detected and understood |
| Know what has been done | Search for reports in shared folders | The records produced by these activities are found and dated; failing that, MAC starts from the market placement date |
| Stay in control | Discover the delay at the audit | A timeline per device: overdue, due soon, up to date |
List the commitments
Without the tool
Re-read every plan by hand, document by document
With My Audit Corner
Exhaustive reading of every document that sets post-market activities
Know the deadlines
Without the tool
Recalculate each frequency in a spreadsheet
With My Audit Corner
The declared frequency (3 months, 6 months, 1 year, 3 years…) is detected and understood
Know what has been done
Without the tool
Search for reports in shared folders
With My Audit Corner
The records produced by these activities are found and dated; failing that, MAC starts from the market placement date
Stay in control
Without the tool
Discover the delay at the audit
With My Audit Corner
A timeline per device: overdue, due soon, up to date
MAC does not carry out the activities for you. It makes sure you never miss one again.
Two ways to move forward
With the tool, by your team
The Continuity module applies to your technical files and your quality system. Your team sees at all times where each commitment stands.
With our experts, on an ongoing basis
For micro and small enterprises, our outsourced PRRC handles the periodic reviews and vigilance, with the platform as its engine.
Frequently asked questions
All those your documents commit to after market placement: post-market surveillance (PMS), post-market clinical follow-up (PMCF), periodic safety update reports (PSUR), and reviews set by your risk management or clinical evaluation.
No. MAC detects the commitments and their frequency in your documents, then finds the latest execution in your records. If no record exists, it starts from the market placement date.
It shows as such in the timeline, with its context: which document promised it, at what frequency, and when it was last carried out.
No. My Audit Corner connects to your existing environment (SharePoint, Google Drive, OneDrive, TraceX) and reads your documents where they are.
The Notified Body will find it. Better to know before they do.
Connect MAC to your documents: for each device, you see which commitments are overdue, which are coming up and which are up to date.