Fixed priceTo get started
Custom gap analysis
An assessment of your ISO 13485 and/or MDR compliance, powered by My Audit Corner and delivered as a prioritised roadmap.
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Experts who deliver, a platform that accelerates.
Gap analysis, audits, technical files, outsourced PRRC: the My Audit Corner team delivers the work for you, with the platform as its engine. You pay for the outcome, not the hours.
Initial scoping is free, with no commitment. Fixed-price services, never billed by the hour.
You pay for the outcome, not the hours
Every service is sold as a fixed-price package with a deliverable defined up front. Never billed by the hour.
The initial scoping is free
Before any proposal, we qualify your real situation together: device class, scope, complexity. No commitment.
My Audit Corner included
Every service includes the platform set-up, operated by our team, with shared access for you throughout the engagement.
How it works
Three steps, from the first conversation to delivery.
1
Free scoping
A first conversation to understand your real situation: product, class, deadlines, constraints. This is where we confirm the scope.
2
A fixed-price proposal
You receive a proposal with a clear scope, deliverable and timeline. Never billed by the hour.
3
Platform-powered delivery
We set up My Audit Corner on your documents and deliver the engagement with the platform as our engine. You keep shared access during the engagement, and the subscription remains available afterwards to continue on your own.
Our services
Four families, depending on where you stand.
1
Know where you stand
A reliable, fast and prioritised assessment before committing to anything.
Fixed price
ISO 13485 internal audit
Your annual internal audit (clause 8.2.4) carried out by an independent auditor, from planning to action plan.
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Supplier audit
Qualification or surveillance of a critical supplier, carried out remotely.
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Pass your audits and submissions
Walk into the Notified Body audit prepared, and answer right when they ask questions.
Fixed price
Mock audit
A simulated certification or Notified Body audit under real conditions, so you can fix things before the real one.
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External audit preparation
Final coaching for your teams before an external audit.
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Technical file review before submission or market placement
A critical, platform-powered review of your MDR technical file before sending it to the Notified Body or, for self-certified devices, before placing them on the market. One round trip avoided with the Notified Body often means six months saved.
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Non-conformity analysis and response
Turn Notified Body non-conformities into solid responses.
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Build
Lay the regulatory foundations of a product, a market or a company.
Fixed price
Regulatory strategy
Your regulatory route, from product qualification to the market launch timeline.
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ISO 13485 QMS build
A complete quality management system, built and operated in My Audit Corner, up to certification readiness.
Learn moreOn quotation
MDR technical file
A complete technical file (MDR Annexes II and III), built with the platform and tailored to your device class.
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Ongoing delegation
Entrust a regulatory function over time, without hiring.
Monthly subscription
Outsourced PRRC
We act as your Person Responsible for Regulatory Compliance (MDR Article 15).
Learn moreMonthly subscriptionTo get started
Custom regulatory watch
MDR, IVDR, MDCG and standards monitoring filtered on your product portfolio, with impact analysis.
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Custom
Product combinations, atypical situations, heavy remediation, multi-site or multi-market: some topics do not fit in any box. We scope them with you, free of charge, before proposing a dedicated engagement.
Why it is more efficient
Because My Audit Corner does the documentary analysis work continuously, our experts spend their time on what matters: judgement, decisions and support. The result: services that are faster, more reliable and more affordable than a traditional consulting engagement, without compromising on expertise.
Frequently asked questions
Yes. Every service includes the set-up of My Audit Corner on your documents, operated by our team, with shared access for you throughout the engagement. At the end, the subscription remains available if you wish to continue on your own.
Every service is sold as a fixed-price package, never by the hour. The amount is confirmed after a free scoping, depending on your device class, the scope and the complexity of the topic.
A member of the team gets back to you very quickly to schedule the scoping. After that conversation, you receive a fixed-price proposal with the scope, the deliverable and the timeline.
Yes. Many clients start with a gap analysis or a custom regulatory watch, then move on to a broader engagement. For complex topics, we put together a custom offer.
No, they are different. With the subscription, your teams work in the platform. With a service, we do the work, with the platform as our engine. The two often go together: an engagement to get started, the subscription to carry on.
A topic that does not fit in any box?
Describe your situation and we will quickly tell you how we can help.