MD and IVD manufacturers
Your products are on the market. MAC keeps them compliant.
Audits, technical files, changes, regulatory watch, post-market commitments: MAC does the groundwork every day, and your quality team stays in control of what matters.
The nonconformities raised during the audit had all been identified by the tool beforehand. No surprises on the day.
You are also: Medtech start-up · In MDR / IVDR transition · Facing RA/QA turnover
What you face
After certification, the work never stops.
Procedures evolve, records are filled in by other departments, references get lost. Nobody sees the gap before the auditor does.
A revised standard can make a product non-compliant. Keeping up takes days every quarter.
A component, a supplier, a marketing claim: every change raises the same questions and involves several departments.
PMS, PMCF, PSUR: commitments made to the notified body pile up, and it is often the surveillance audit that brings their deadline back.
What MAC does for you
The groundwork, done every day.
Your QMS assessed continuously
Procedures and records assessed requirement by requirement, inconsistencies between documents flagged, an action plan ready to follow. On audit day, there is nothing left to prepare.
See it in the platformYour technical files kept up to date
GSPR, risk and clinical consistency, design traceability, pre-submission check, consistency with EUDAMED.
See it in the platformEvery change assessed
Describe the change: MAC measures its regulatory impact, says whether it is substantial and prepares the committee note.
See the use caseYour post-market commitments tracked
MAC finds every commitment made and tells you what is overdue, coming up or up to date.
See the use caseAudit nonconformities closed fast
Upload the report: MAC finds the evidence in your documents and drafts the responses, root cause and impact included.
See the use caseThe whole company informed
Marketing, production and R&D find sourced answers without going through the quality team. Management follows a score per product.
See it in the platformWe are going to save precious time on internal audits. We run about ten a year, and each one ties up several people for half a day, not counting preparation and the report.
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.
We are already certified. What is MAC for?
That is where it helps most: evolving documents, changing standards, product changes, PMS and PMCF commitments. MAC follows all of this continuously and flags what drifts before the surveillance audit.
We have several sites or subsidiaries.
MAC brings the compliance of all your quality systems into the same interface, with a score per site and per product.
Do we need to change our tools?
No. MAC connects to your existing tools (SharePoint, Google Drive, OneDrive, TraceX, Odoo, Confluence, Jira) and reads your documents where they are.
See MAC at work on your own products.
30 minutes with our team: you connect your documentation and MAC produces its first analyses.