Post-market surveillance and vigilance, on time
I set up and run post-market surveillance and vigilance for your device, from complaints and trend reviews to reporting to the authorities, so what you learn from the field feeds back into the product and the risk file. I've handled complaints, vigilance and recalls from inside a company, so I know what it takes when a report has to go out on time.
Three situations where this works best
Complaints, field data and reporting obligations started with the first sale.
PMS reports and PSURs are due, and nobody owns them.
MDR asks for more post-market data, more often, than the MDD did.
Your device is on the market
Reports are late
You moved to EU MDR
You are not sure which events need to be reported, to whom and by when.
Complaints are logged but never reviewed for trends.
Your PMS reports or PSURs are behind schedule.
The post-market data never reaches the risk file.
You sell in several markets with different reporting rules.
You probably need this if one of these sounds familiar
Field data that comes back into the product
A plan, a schedule and data sources that match your device and its class.
Regular trend reviews, so a signal is noticed early.
Clear criteria for what is reportable in each market, and by when.
Post-market findings flow into risk management and CAPA.
A PMS system that runs
Complaints and trends reviewed
Reporting on time
Data that feeds back
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
This year I prepared the complete post-market surveillance package for a dental navigation company I support on an ongoing basis. It included the PMS report, followed by the PSUR with the PMCF evaluation report and a trend analysis.
A full PMS package
Yes. I align the quality system and the technical documentation with MDR, update PMS and vigilance, and prepare you for the notified body audit.
Yes. Most of my work is remote, with companies in Europe, North America and Israel. When a project needs me on site, we plan it together.
Both are possible. Many clients start with a project and continue with a few hours a month of ongoing support. I work by the hour, and offer a fixed price only when the scope is closed and known in advance.
We're moving from MDD to EU MDR. Can you help?
Do you work with companies outside Israel?
How do engagements typically work – project-based or ongoing?
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A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.