Solutions

Start from your situation. MAC takes care of the rest.

A submission coming up, an audit report to handle, a device change, someone leaving the team: each page shows what MAC actually does in that specific case.

By need

What is on your plate right now?

Submit and certify

The file has to go out complete, and moving to the MDR or IVDR must not break anything.

Your technical file is going out soonCompleteness, consistency and compliance checked before the notified body, with help to draft what is missing.You are moving from the MDD to the MDR or IVDRYour existing files assessed against the new requirements, document by document.

Audits and notified bodies

What the auditor found, and how to respond fast.

You have received a non-conformity reportMAC finds the evidence in your documents and drafts your first responses.

Your products on the market

Once certified, compliance is a daily job.

Your PMS and PMCF commitmentsWhat you promised your notified body: overdue, due soon or up to date.A device change to assessSubstantial or not, documents affected, committee note: in minutes.

Your quality system

A QMS you master as a whole, not just piece by piece.

You are taking over an inherited or patchwork QMSIts real state requirement by requirement, the inconsistencies between documents, then a prioritised action plan.

Your team

Compliance should not depend on a single person.

Someone is leaving the quality team, or joining itThe memory of the QMS and files stays, and a newcomer is up to speed in days.

Your need is not on the list?

Tell us what you are dealing with.

We add pages as our customers bring us new requests. Describe your situation and we will show you what MAC can do for your case.

By profile

You are mostly a…

MD or IVD manufacturer

Your products are on the market: a QMS assessed continuously, technical files kept up to date, audits without surprises.

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Medtech or biotech start-up

A first CE marking without a full RA/QA team: what is missing, in what order, and how.

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Medtech subcontractor

Customers auditing you one after another: a QMS that is always ready and solid evidence to show.

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Not sure where to start? Show us your situation.

In one demo, we start from your documents and your regulatory agenda. You leave knowing what MAC changes for you.

See our services