Medtech and biotech start-ups
A first CE marking, without a full RA/QA team.
MAC tells you what is missing, in which order to do it and how, from building the QMS to submission. Then it keeps your products compliant once on the market.
The system scans the entire standard, completely and far more often, where an internal audit only samples.
You are also: MD / IVD manufacturer · In MDR / IVDR transition
What you face
Regulation should not slow down your launch.
One or two people carry the QMS, the technical file, the regulatory strategy and the exchanges with the notified body.
Every change to the product or the target calls into question documents already written, and inconsistencies settle in.
One missing document, one traceability gap, and the file comes back. Every month of delay costs cash.
The product is on the market: now you must maintain the QMS, follow standards and post-market commitments, with the same team.
What MAC does for you
Moving forward in the right order, without forgetting anything.
A QMS built requirement by requirement
MAC assesses what exists and tells you what is missing, in order, with the content to produce. You move towards certification with no blind spot.
See it in the platformA technical file ready to submit
GSPR, risk and clinical consistency, design traceability, missing documents: everything is checked before the notified body.
See it in the platformPivots under control
When the product evolves, MAC tells you which documents are affected and what needs to be reworked.
See the use caseA regulatory watch that does not slip
The standards and guidance applicable to your device are followed for you, with their impact on your documentation.
See it in the platformFigures for your investors
A score per product and a dated action plan: you know, and you can show, where your compliance stands.
For our teams to have a clear mind for R&D and creating value for patients, rather than spending their time on legacy regulatory work.
Services
Would you rather we did it for you?
Our experts deliver the service, with the platform as their engine. You pay for the outcome, not the hours.
Your questions, answered.
Our QMS does not exist yet. Is it too early?
No. MAC is useful from the very first documents: it tells you what is missing and in which order to produce it. The Starter plan is designed for one product and a QMS being built or just certified.
Does MAC replace a consultant?
MAC does the groundwork (assessing, flagging gaps, suggesting content); strategy and decisions remain yours. For topics that need an expert, our Services take over.
How much does it cost?
From €350 excl. VAT per month, with every feature and unlimited users.
Secure your route to CE marking.
30 minutes with our team: you connect your first documents and see what is missing.