Services

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.

Free scoping

A first conversation to understand your real situation: product, class, deadlines, constraints. This is where we confirm the scope.

A fixed-price proposal

You receive a proposal with a clear scope, deliverable and timeline. Never billed by the hour.

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.

Know where you stand

A reliable, fast and prioritised assessment before committing to anything.

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.

What you get

Platform-powered documentary analysis of your QMS and files
Interviews with your teams
Gap matrix by requirement
Prioritised roadmap

Good to know

Delivered in less than a week
Variant: impact analysis of a new regulatory requirement on your product portfolio

Ideal if: you do not know exactly where you stand before an audit, a submission or a new project, and you want a reliable roadmap within days.

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.

What you get

Audit plan
Audit execution
Audit report
Action plan

Good to know

Scope: one site

Ideal if: you have no independent auditor in-house, or the annual audit is coming up and the team has no time to run it properly.

Fixed price

Supplier audit

Qualification or surveillance of a critical supplier, carried out remotely.

What you get

Assessment questionnaire
Remote audit
Audit report
Follow-up of actions

Good to know

Remote audit only

Ideal if: a critical supplier needs to be qualified or monitored and you have neither the time nor the checklist to do it by the book.

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.

What you get

Audit under real conditions
Findings report
Prioritised remediations

Good to know

ISO 13485 certification or Notified Body audit

Ideal if: your certification or Notified Body audit is scheduled and you want to find the gaps before the auditor does.

Fixed price

External audit preparation

Final coaching for your teams before an external audit.

What you get

Documentary review
Team preparation
Interview rehearsals

Good to know

To be scheduled in the weeks before the audit

Ideal if: your teams have never been audited, or the last audit went badly, and there are a few weeks left to prepare.

Fixed price

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.

What you get

Completeness of the general requirements (GSPR)
Compliance with applicable standards
Overall consistency of the file
List of blocking points

Good to know

All classes, from class I to class III and implantable devices, where an independent review matters most
Scope confirmed after scoping, depending on the class and the size of the file

Ideal if: this is your first MDR submission, nobody has challenged the file from the outside, or you are placing a class I device on the market without going through a Notified Body.

Fixed price

Non-conformity analysis and response

Turn Notified Body non-conformities into solid responses.

What you get

Root cause analysis
CAPA plan
Drafting of the responses
One exchange cycle with the Notified Body

Good to know

Per batch of non-conformities

Ideal if: you have just received a non-conformity report and the deadline to answer the Notified Body is short.

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.

What you get

Qualification and classification
Applicable requirements and standards
Market access route
Action plan and timeline

Good to know

Typical cases: new product, new market, new country

Ideal if: you are launching a new product, targeting a new market or a new country, and the regulatory route is not mapped yet.

Fixed price

ISO 13485 QMS build

A complete quality management system, built and operated in My Audit Corner, up to certification readiness.

What you get

Processes and procedures
Records and management tools
QMS operated in the platform
Certification readiness

Good to know

Small company, one site
Certification body fees not included

Ideal if: you are starting from scratch or from an incomplete system and aiming for ISO 13485 certification without hiring a quality team.

On quotation

MDR technical file

A complete technical file (MDR Annexes II and III), built with the platform and tailored to your device class.

What you get

GSPR
Risk management
Design documentation
Labelling
Clinical evaluation coordination
Compliance with applicable standards

Good to know

All classes (I, IIa, IIb, III)
Clinical Evaluation Report (CER) as an option

Ideal if: you need to build your first MDR technical file, or rework an existing one before a submission.

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).

What you get

Periodic reviews
Documentary compliance
Vigilance

Good to know

Micro and small enterprises (MDR Art. 15(2))
Subscription with no long-term commitment

Ideal if: you are a micro or small enterprise and nobody in-house meets the conditions to hold the PRRC function.

Monthly subscriptionTo get started

Custom regulatory watch

MDR, IVDR, MDCG and standards monitoring filtered on your product portfolio, with impact analysis.

What you get

Qualified alerts
Impact analysis on your products
Monthly summary

Good to know

Goes further than the platform's free watch: every alert is analysed for your portfolio

Ideal if: your portfolio spans several standards and nobody has time to sort out what really applies to you in each new publication.

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.