Medtech subcontractors
Demanding customers, one audit after another. A QMS always ready.
Every manufacturer customer audits your quality system. MAC keeps it assessed continuously and gives you solid evidence to show, without tying up your quality manager for days.
Thank you for being so responsive, and what pleases me most is that I had nothing to do!
You are also: MD / IVD manufacturer · Facing RA/QA turnover
What you face
More customers, more audits.
Ten manufacturer customers can mean ten supplier audits a year, checking almost the same things.
As a critical subcontractor, you can be audited by a customer's notified body. A gap on your side can block their CE marking.
Without ISO 13485, you are invisible to most manufacturers. Maintaining it keeps a small team busy all year.
Internal auditor, document control, CAPA, customer audits: often one person carries it all.
What MAC does for you
Quality as a sales argument.
A QMS assessed continuously
Procedures, records, work instructions: MAC flags what is outdated or inconsistent before your customers do.
See it in the platformCustomer audits prepared in hours
A score per requirement, backed by quotes from your documents: you present an objective status rather than rebuilding everything for each audit.
Assisted internal audit
A checklist built on your documentation and a drafted report: the internal audit no longer depends on an available auditor.
Nonconformities closed fast
Whether they come from a customer or the certification body, MAC finds the evidence and drafts the responses.
See the use caseChanges in standards anticipated
MAC follows the standards that concern you and tells you what they change for your documentation.
See it in the platformThe points My Audit Corner raised are exactly the ones worth discussing. We no longer start from a blank page as in a classic audit.
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 do not manufacture our own devices. Is MAC suitable?
Yes. MAC assesses your ISO 13485 QMS and prepares your customer audits; the technical file features remain available if you need them.
Can we show the results to our customers?
Yes: assessments quote your documents and can be exported. You choose what you share.
How long does it take to get started?
A few hours: you connect your documentation and MAC starts analysing. With the Launch Pack, you hand us a real case and see MAC's result before you commit.
Turn your QMS into a competitive advantage.
30 minutes with our team: you connect your documentation and see your QMS assessed.