Your products
Complete technical files. Products that stay compliant.
Before submission and after CE marking, MAC checks every file, measures the impact of every change and tracks your post-market commitments.
Example · Product portfolioWhat MAC does for your products
From the first file to life on the market.
Pre-submission check
Before any exchange with the notified body, MAC goes through the entire technical file and flags missing documents, signatures or mandatory data. A 10,000-page file is checked in 15 minutes.
GSPR, risk and clinical consistency
MAC follows the thread between your general safety and performance requirements, your risk management and your clinical evaluation. A risk not covered clinically is flagged immediately.
Design traceability
From design inputs to design outputs, through verification and validation: MAC spots orphan or untested specifications before they block your CE marking.
Classification and applicable requirements
MAC checks your device class against the MDR or IVDR rules, identifies the requirements and standards that apply, and verifies that your choices are justified.
Consistency with EUDAMED
MAC checks your EUDAMED declarations against your documentation and flags discrepancies before they become an audit finding.
An action plan per file
Every gap or inconsistency becomes a precise action, with suggested content, so your engineers fix it without losing time on interpretation.
Impact of a product change
Describe a change: component, claim, supplier. MAC assesses its impact on your requirements and documents, argues whether it is substantial, identifies the departments involved and prepares the committee note, exportable as a PDF.
See the use casePost-market commitments tracked
MAC finds in your documents the commitments made to the notified body (PMS, PMCF, PSUR) and tells you, activity by activity, what is overdue, what is coming and what is up to date.
See the use caseA huge time saver: gaps are detected very, very quickly.
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.
The other areas
One tool to keep everything compliant.
Your questions, answered.
Does MAC cover medical devices and IVDs?
Yes: medical devices (MDR 2017/745) and in vitro diagnostic devices (IVDR 2017/746).
Our product is already CE marked. What does MAC bring?
The file lives on after CE marking: changes, evolving standards, post-market data. MAC reassesses whatever each change affects and tracks your PMS and PMCF commitments, so the file stays up to date from one audit to the next.
Does MAC write the technical file for us?
MAC tells you what is missing and suggests the content to insert; your team reviews, adjusts and approves. If you would rather have the file written for you, our experts do it as part of our Services.
How many products can we follow?
As many as your business needs: the plan is sized on your portfolio, with every feature and unlimited users.
See your technical file checked by MAC.
30 minutes with our team: you connect your documentation and MAC produces its first analyses on your own products.