About

Two senior consultants. Who have worked client-side.

ISOFAC GROUP is not yet another consultancy with a tidy website. Our two consultants spent years in-house with manufacturers, with direct responsibility for quality, regulatory affairs and strategy. We know what a poorly scoped file, a forgotten PMS or a postponed management review costs. Our deliverables are written by people who have used them, not by people who merely watched them go by.

Talk to us →
Our conviction

Useful compliance, not decorative compliance

Too many regulatory files are built to pass an audit, not to serve the product. Too many quality systems exist in a binder without irrigating daily practice. Too many clinical evaluations are copy-pasted from one file to the next. The result: companies that scrape through their audits at the last minute, that pay again at every cycle, and that learn nothing.

We believe the opposite. Regulatory compliance is useful when it integrates into how the company is run, when it feeds product and strategic decisions, when it genuinely protects patient safety. Our engagements are calibrated for that. Not to produce a deliverable, but to build a capability.

Founders

Thomas Trullen and Jonathan Bedin

Two complementary backgrounds, one shared conviction.

Thomas Trullen

Co-founder — Senior quality, regulatory and strategy consultant

Montpellier, France

Before co-founding ISOFAC GROUP, I spent several years with medical device manufacturers, in charge of quality, regulatory affairs and product strategy. I led CE markings from Class I to IIb, structured technical files under Annexes II and III of the MDR, and ran complete QMS overhauls ahead of notified body audits.

That background has a direct bearing on how I work: I know the cost of a poorly scoped file, a questionable classification, a QMS that doesn't hold up in audit. I don't walk into a consulting engagement without having had that problem on my own hands.

Alongside ISOFAC GROUP, I work as an AFNOR-certified auditor for ISO 13485 and MDR audits with AFNOR Certification (notified body 0333). This dual position feeds every engagement: I write deliverables with the eye of the auditor who will receive them.

My scope covers ISOFAC GROUP's three pillars: quality (ISO 13485 QMS, audits, process overhaul), regulatory (MDR, technical file, CE marking, PMS, vigilance) and strategy (aligning regulatory strategy with the company's objectives).

Malt

Domaines

  • MDR regulatory consulting
  • CE marking — Classes I to IIb
  • Technical file (Annexes II & III)
  • Clinical evaluation & PMS
  • EC REP
  • ISO 13485 & MDR auditing
  • ISO 13485 — QMS

Certifications

  • · AFNOR auditor (ISO 13485 / ISO 19011)
  • · European MD regulation specialist (MDR)
  • · ISO 14971:2019 risk management

Jonathan Bedin

Co-founder — Quality & Regulatory Affairs

Montpellier, France

Before co-founding ISOFAC GROUP, I spent eight years on the manufacturer side, on Class I to IIb devices: SaMD, respiratory devices, diagnostic equipment. Management reviews, non-conformity handling, CAPA, certification audit preparation, leading quality teams. I lived the friction points of a QMS under real conditions, not in simulation.

What shaped me as much as the certifications: understanding why a process drifts in production, why a CAPA stays open for six months, why an audit reveals what the internal team no longer had the distance to see. That is where I work from today.

A certified ISO 13485 auditor (AFNOR) and holder of a Master's degree in Health Engineering, Medical Devices specialty (Faculty of Pharmacy of Montpellier), I cover the full quality scope: QMS build and overhaul, risk management (ISO 14971), medical device software (IEC 62304), usability (IEC 62366), PMS and vigilance.

At ISOFAC GROUP, I handle ISO 13485 audit engagements, certification support and quality system builds, for manufacturers, importers and distributors that need a structured, operational quality function.

Domaines

  • ISO 13485 auditing
  • QMS build and overhaul
  • ISO 14971 risk management
  • SaMD — IEC 62304
  • Usability IEC 62366
  • PMS and vigilance
  • Outsourced QARA management

Certifications

  • · MSc Health Engineering — Medical Devices specialty, Faculty of Pharmacy of Montpellier (2018)
  • · ISO 13485 audit training — AFNOR
  • · Languages: French, English
Our approach

Four principles that structure every engagement

Principle What it means in practice
PragmatismWe work with your SME's real resources, not those of a listed group. Our action plans are calibrated on what can actually be sustained, not on an ideal that will never be executed.
RigourEvery deliverable is written with its regulatory reference, its rationale and its evidence. We never hand over a document we couldn't defend ourselves in an audit.
ProximityYou have a single point of contact, who takes your calls, knows your files and replies within 48 hours. No hidden delegation to a junior.
Knowledge transferBy the end of an engagement, your teams master what was produced. We document, we train, we leave a role that can be held. No engineered dependency.
Where we work

France, Europe, non-EU manufacturers

Our engagements cover the whole of France, on site or remotely. For manufacturers established outside the EU, ISOFAC GROUP is registered in EUDAMED as a European Authorised Representative within the meaning of Article 11 MDR. This lets a non-European manufacturer rely on a single point of contact for regulatory strategy, technical file construction and European representation.

  • All of France — regional travel included in the fee up to 200 km
  • 27 EU Member States — Europe-wide engagements on quote, expenses at cost
  • Non-EU manufacturers — EC REP registered in EUDAMED
35
Clients supported
100+
Audit days delivered
14 yrs
Of combined experience
Our commitments

What we guarantee by contract

Commitment Detail
Reply within 48hEvery enquiry receives a written, substantive reply within 48 working hours.
Free scopingThe first exchange and the scoping note are free, with no commitment, under NDA if you wish.
Firm quoteOnce the scope is set, we commit to an amount and a schedule. No drift during the engagement, unless you explicitly request it.
Actionable deliverablesOur deliverables are written to be used. No decorative reports: every section carries a recommendation, a piece of evidence or an action plan.
An owned noIf we are not the right answer to your need, we say so and point you elsewhere. A clear no beats a poorly scoped engagement.

Want to know more about how we work?

Tell us about your situation. Within 48 hours we'll confirm whether a deeper conversation makes sense.

Talk to us →