A clear route to market, and a file that supports it
I work out which frameworks apply to your device and what it takes to register it, then build the technical documentation with your team and take the product through to registration. I've taken products through approval in the US, Europe, Australia, Asia, Latin America and Russia.
Three situations where this works best
You need to know the classification, the route and what the file has to contain before you commit to a timeline.
The device is sold in one market, and you want to know what changes for the next one.
The documentation was built for the MDD, or in pieces, and it has not been checked against EU MDR Annex II and Annex III.
You are planning your first market
You are adding a market
Your technical file needs work
You are not sure how your device is classified under EU MDR or by the FDA.
You need to choose between the regulatory routes open to you.
Your technical documentation has never been reviewed as a whole.
A notified body or an authority sent questions about your file.
You want one plan that covers Europe, the US and other markets.
You probably need this if one of these sounds familiar
A plan for each market, and the file to back it
The classification, the route for each market and the order of the steps, in writing.
A file that is complete and consistent with the requirements of each market.
Answers to the notified body's or the authority's questions until the product is registered.
A regulatory strategy
Technical documentation that holds together
Support through registration
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
A company preparing the CE marking of its in-vitro diagnostic device under the former IVD Directive brought me in to build the technical documentation with them. I provided document templates, guided the team through the standards and requirements that applied to their device, and stayed available for quick answers along the way. The documentation was complete and tight, and the device received its CE marking.
A CE submission built together
ISO 13485, EU MDR, EU IVDR, FDA QMSR (21 CFR Part 820), MDSAP, ISO 14971 for risk management and IEC 62304 for medical device software.
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.
Which regulatory frameworks do you work with?
We're moving from MDD to EU MDR. Can you help?
Do you work with companies outside Israel?
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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.