Quality & regulatory consulting in medical devices
Our mission: to transmit best practices and build autonomy within your teams & turn your compliance into a competitive advantage.
Montpellier · France · Europe
We firmly believe that quality and regulatory compliance is not an administrative constraint, but a pillar of patient safety and industrial performance.
What drives us: making regulation accessible, useful and effective.
“ Because a quality system has value only if it genuinely improves practices and safety. Because a medical device only makes sense if it was designed with the patient in mind. ”
This conviction we carry together. With the same standard: regulatory rigour can, and must, be a driver of excellence.
Thomas Trullen — Jonathan Bedin
Discover our backgrounds →References
Decide before you execute. Build before you prove. Audit before others do. And represent in Europe those who are not established there. ISOFAC GROUP operates across all four stages, without subcontracting any of them.
Before filling in documents, you decide. The phase where one good decision saves months, and one bad one costs as much.
Once the strategy is set, you have to produce. A solid technical file, a QMS that holds up under audit, usable clinical data, post-market surveillance that does not sit dormant in a folder.
Gap analysis, annual internal audit, pre-certification mock audit. Conducted by a certified ICA 13485 auditor, product evaluator at a notified body. The perspective of someone who reviews files, applied to the preparation of yours.
Without an authorised representative established in the Union, there is no access to the European market. ISOFAC GROUP assumes this responsibility under Article 11 of Regulation (EU) 2017/745 for non-EU manufacturers.
Your situation
Each profile has its own entry point. Identify yourself, access what truly concerns you.
Quality management system, technical documentation, clinical evaluation, post-market vigilance, EUDAMED registration… Every aspect of your activity will be assessed in detail.
Every non-EU manufacturer must designate a European authorised representative established in the Union. This mandate creates joint liability for the representative; the choice is not trivial.
Importers and distributors have specific obligations: document verification, incident reporting, record retention. You are responsible for what you sell.
Mock audit, certification support, ongoing quality management system monitoring; ISOFAC GROUP structures your processes to withstand the renewal audit.
Technical file recovery, supplier audit, regulatory due diligence — rapidly identify critical gaps, document compliance status, prioritise corrective actions.
Why ISOFAC GROUP
Four commitments that define how we work.
01
The partner who takes your project is the one who runs it, delivers it and stands behind it. No project manager layer, no junior handover, no mid-mission restart. You deal with an identified senior consultant, reachable, who argues your decisions before the notified body as if they were his own.
And because engaging a senior consultant only makes sense where it adds real value, we draw a clear distinction between what falls under strategy and expertise, where we intervene directly, and what falls under operational execution, which your teams can handle after a proper briefing. You pay for senior input on decisions, not for document population. That, too, is what a well-calibrated regulatory budget looks like.
02
ISOFAC GROUP's consulting rests on an expertise exercised in the present. Thomas Trullen is a certified ICA 13485 auditor and product evaluator for a notified body, currently active on manufacturer certification files. Jonathan Bedin brings industrial practice and operational mastery of quality systems, audits and MDR compliance.
This dual foundation allows us to intervene with the same rigour, whether you are a manufacturer, importer, distributor, subcontractor or a non-EU manufacturer in search of a European authorised representative.
ISOFAC GROUP has no ties to any manufacturer, equipment supplier or distributor. The advice you receive has one single objective: the robustness of your compliance, not the promotion of a commercial partner.
03
A mission is not complete when the file is submitted. It is complete when your quality and regulatory staff know how to maintain it, defend it and evolve it without us.
In practice: we document our decisions, explain methodological choices, and train your teams on the points that will fall back to them. At the end of the mission, you retain a file, but above all people capable of managing it.
That is what distinguishes a competence transfer from a simple delivery.
04
An on-site audit, a workshop observation, support during an inspection or a notified body visit: these are moments that require physical presence, because you see there what no document captures. On these missions, travel is systematic.
A progress update, a procedure review, a methodological decision: video call saves time for everyone, without any loss of quality.
Based in Montpellier, we work across France and Europe. The criterion is not distance; it is whether the trip serves the mission.
Montpellier · France · Europe
First contact
No lengthy intake form, no commercial pre-qualification. A phone call with the person who will run the project, to understand your situation and tell you whether we can be useful.
01
A short email, a message via the form, or a direct call to the number shown. You explain the context in a few lines: your device, your deadline, what is blocking you. No need to prepare anything; we will work through it together.
02
No filter, no assistant, no account manager. Thomas Trullen receives your message and replies directly. If I am on a site mission, you receive a message stating this and the date when we can speak.
03
A scoping call, no commitment. We look at your file, your deadline, your constraints together. At the end, you know whether an ISOFAC GROUP engagement makes sense for you, and if so, in what form. If not, I direct you to the relevant resource.
FAQ
There is no standard rate, but we can give meaningful ranges. Full MDR technical file support for a Class IIa manufacturer generally runs between €15,000 and €60,000, depending on device complexity and starting point. ISO 13485 certification preparation for a small company with no existing QMS generally falls between €20,000 and €50,000. These ranges are not a quote; they calibrate your expectations before an initial conversation.
For a Class IIa manufacturer starting from a near-nonexistent QMS: 9 to 15 months. For an MDR technical file on a device already marketed under MDD: 6 to 12 months, depending on the current file's conformity level. These timelines include the post-gap-analysis remediation phase.
As early as possible, and ideally from the design phase. Many manufacturers contact us when development is already advanced, sometimes even when the file is already assembled. At that stage, certain decisions are no longer reversible without significant cost: classification choices, clinical evaluation scope, validation strategy. An upstream intervention allows these choices to be framed while they are still open.
This does not mean a long engagement: a few days of scoping at the start of a project often prevents several weeks of rework at the end.
For manufacturers already engaged in a process, it is also worthwhile to consult before each key milestone: classification review, technical file finalisation, audit preparation, notified body submission.
A rejection or suspension is never the end of the road, but it is a signal that demands a structured response. Depending on the nature of the gaps identified (major non-conformities, information requests, conformity doubts), the response deadlines imposed by the notified body are short, generally 30 to 90 days.
The first step is to understand precisely what is at issue, which is not always straightforward from reading the report. Then a response plan must be built that addresses each point without opening new ones: a file that overcorrects is as risky as one that undercorrects.
ISOFAC GROUP is regularly engaged in these situations, sometimes following a first, unsatisfactory intervention. The earlier the engagement after notification of the gap, the more room there is to manoeuvre.
The MDR draws a clear distinction between roles: manufacturer, authorised representative, importer, distributor. Each role carries specific obligations, and the same operator may hold several simultaneously depending on the nature of its activities in relation to medical devices.
Frequent sources of confusion: a distributor that modifies labelling potentially becomes a manufacturer under Article 16 MDR; an importer that affixes its own brand to a non-EU product may shift into manufacturer status; a subcontractor that designs to the principal's specifications is generally not a manufacturer, but must nevertheless meet precise contractual requirements.
A clear qualification of your status is a prerequisite for any compliance effort. We conduct qualification audits to resolve ambiguous cases, in days rather than weeks.
Not automatically. The European authorised representative must be formally designated by the manufacturer to assume a specific legal role defined by Article 11 MDR: interface with competent authorities, technical documentation custody, shared responsibility for certain obligations.
An EU subsidiary can indeed take on this role, but only under specific conditions: it must be formally designated by written mandate, possess the necessary regulatory competence, and accept the shared liability provided for by the regulation. Many commercial subsidiaries are not structured for this function, which creates non-conformity situations that are often overlooked.
Before externalising or internalising the authorised representative role, we recommend an audit of the existing arrangement. This allows an informed decision, and a compliant solution to be structured: a reinforced internal representative, a specialised external representative, or a hybrid solution depending on the product lines.
A first 30-minute call allows us to assess your situation and tell you honestly whether we are the right contact. If we are not, we will direct you accordingly.