Every PMCF program ultimately answers one question:
“Will our Notified Body accept this evidence?”
If the answer is uncertain, the program is already at risk.
Many platforms promise better data collection.
Few understand what regulators actually expect to see.
Because most vendors have never sat on the other side of a certification review.
The reality of MDR today
Notified Bodies are increasingly focused on:
- auditability
- traceability
- methodological rigor
- data integrity
- documented justification
“Survey results” alone are not enough.
They want to see:
- how the data was captured
- who entered it
- whether it was altered
- whether it is complete
- whether it can be trusted
This is not a user experience problem.
It is a compliance problem.
Where 1MED has a unique advantage
1MED SA works directly with Notified Bodies every day.
We:
- prepare Technical Documentation
- support certifications
- respond to NB findings
- defend PMCF strategies
- liaise during audits
And we maintain a 100% success rate across 300+ certifications
This means we don’t guess what regulators expect.
We already know.
Because we build submissions with them constantly.
How that shapes 1SURVEY+
When we built 1SURVEY+, we didn’t design it like a survey tool.
We designed it like a regulatory system.
Every dataset is:
- timestamped
- traceable
- audit-ready
- structured for CER/PSUR inclusion
The outputs are not “charts.”
They are submission-ready evidence packages.
That alignment comes directly from our NB experience.
It’s not something software vendors can replicate.
Why this matters for manufacturers
When deadlines are tight, the biggest cost isn’t data collection.
It’s:
- rework
- NB questions
- non-conformities
- resubmissions
Choosing a partner that understands how regulators think eliminates that risk upfront.
Bottom line
If PMCF evidence must pass Notified Body scrutiny, work with a partner who already does.
Regulatory credibility cannot be coded into software.
It’s earned through experience.
Schedule a demo to see how 1Survey+ turns feedback into product intelligence demo@1med.net
