MD / IVD Manufacturers: Delegate the operational load.
Daily life in an RA/QA department is a race against the clock. Let your MAC assistant handle your internal quality audit, keep up with regulatory monitoring, verify your product files, and continuously oversee your quality processes. Secure your CE marking for medical devices and in vitro diagnostics — and cut your analysis time by 10x.
See how MAC helps in these specific cases:
The 7 missions of your AI Assistant
Each mission targets a real pain point in your daily work and solves it with a concrete, automated, and immediate answer.
Secure the MDD/IVDD to MDR/IVDR transition
Your reality
Moving to Regulation 2017/745 requires rebuilding your CE marking Technical File, with a very high risk of rejection by the Notified Body.
The MAC solution
MAC performs an exhaustive, cross-referenced evaluation of your files. It detects classification inconsistencies and broken cross-references far better than the human eye, and delivers a ready-to-use action plan for a controlled submission.
Continuous documentation oversight for everyone
Your reality
Chasing R&D for a risk assessment, or chasing production for open non-conformity reports.
The MAC solution
You are no longer the compliance police. MAC continuously monitors your QMS software. The assistant detects missing, inconsistent, or outdated documents and generates a global "Scoring". You drive compliance with data — not with reminders.
When we update a document, we have no tool to quickly trace the links. We don't know what impact it might have on other forms. Having this consistency check feature is excellent.
Document management — for instance links between documents that can disappear — is a daily problem. My Head of Quality asked me to build a tool to identify all documents referencing a specific procedure. On this, the platform can really help us a lot.
Audit readiness (annual and unannounced)
Your reality
The anxiety of an unannounced audit, or the intense stress of the week before a certification audit.
The MAC solution
With MAC, you reach complete peace of mind before the Notified Body arrives. During the audit itself, use the "Ask MAC" feature: ask the auditor's question to your assistant, and it instantly surfaces the relevant procedure and record.
We can clearly see how to use the platform to run a full status review ahead of major events like a large audit.
Accelerated onboarding for your RA/QA teams
Your reality
Onboarding a new team member takes weeks. Between reading, absorbing, and understanding the complex architecture of your QMS software and technical files, they are not operational.
The MAC solution
Your AI assistant eliminates passive learning. New hires no longer need to dig through documentation blindly: MAC directly shows them identified gaps, explains the regulatory context, and hands them a precise, ready-to-execute action plan. They are fully operational and delivering value from day one.
Absolute mastery of regulatory monitoring
Your reality
Tracking standards is time-consuming (often a full day every 3 months) and prone to human error against 200+ reference documents.
The MAC solution
From uncertainty to strategic anticipation. Your assistant digests regulatory complexity, monitors changes (ISO 13485, MDR/IVDR), and runs real-time Gap Analyses to identify impacts on your Technical File.
In terms of impact, your solution will massively simplify my compliance planning. When leadership asks when we can launch a CE-marked product, it will be much easier to commit to a reliable date because the Gap Analysis will already be done.
Internal audits on autopilot
(Even without an expert on hand)
Your reality
Running an ISO 13485 internal audit is an annual stress event. SMEs often lack qualified internal auditors capable of relevant assessments.
The MAC solution
Turn your internal audits into a calm routine. Your assistant generates an expert checklist (500 to 800 questions), pre-analyzes your documents, assigns a justifiable score (A to F), and delivers an actionable plan in 2 hours. All you have to do is validate.
We're going to save precious time on internal audits. We run about ten per year — each one mobilizes several people for half a day, not counting preparation and reporting. That's a real benefit.
Steer your growth (multi-site & suppliers)
Your reality
You are a mid-sized manufacturer with several subsidiaries, multiple quality systems to harmonize, or dozens of critical suppliers to monitor.
The MAC solution
An assistant with the gift of ubiquity. Oversee the compliance of all your subsidiaries from a single dashboard. Coming soon: automated analysis of your supplier certificates and impact assessment on component changes.
One AI — two winners.
For Leadership & CFO
Internalize the expertise: The rigor of a premium auditor, in-house and available 24/7. Accelerate the time-to-market of your medical devices to generate revenue faster. Optimize your external consulting budgets and maximize the ROI of your internal teams by refocusing them on strategy.
For RA/QA Leadership
Lighten your team's mental load. No more repetitive tasks and no more fear of human error. Regain full mastery of your processes, with a new level of day-to-day comfort — thanks to a "100% Plug & Play" tool.
What really makes me happy is that I have nothing to do to set it up!
Ready to hire your best performer?
Connect your document repository today and watch your MAC assistant generate its first reports and action plans.