Consulting ISOFAC GROUP

Quality and regulatory consulting

Two disciplines. One standard of rigour.

Advisory brings strategic or technical expertise your team does not have in-house. Consulting fills a quality or regulatory role within your organisation for a defined period.

We worked inside manufacturers before moving into consulting. We know the real constraints of quality and regulatory work in industry, not just the texts.

ISO 13485 · MDR

Standards mastered

Classes I to IIb

Scope of expertise

27 technical documentation

MDR certified

Describe your need

A written, reasoned reply within 48 working hours. If your request falls outside our scope, we point you to the right resource.

Our approach

Advisory and consulting: two distinct logics, two dedicated approaches

Depending on your needs, an engagement takes a different form. We distinguish two families of mission that respond to distinct logics, without being in opposition.

Advisory steps in when your file requires precise technical mastery your team does not have, or does not have time to build: strategic framing before a CE marking, overhaul of technical documentation under Annex II, response to a notified body non-conformity within the imposed deadlines. We remain external to your organisation.

With notified bodies and authorities, we serve one shared objective: patient safety and regulatory conformity. We pursue it with the pragmatism that SME reality demands.

ADVISORY

Strategic advisory

Before development: classification, intended purpose, conformity pathway.

Before a device leaves the design office, certain choices commit the years ahead. Medical device classification, scope of clinical indications, regulatory conformity pathway: these are decisions that determine the cost, timeline and value of your file. The same question arises before a sale or fundraising round: a structured regulatory file protects value, a vague one destroys it. We intervene at these moments, not to produce a deliverable, but to frame a decision.

Learn more about Strategy & Due Diligence →
ADVISORY

Expert advisory

On a specific topic that requires specialist competence.

Your teams know their business. On a specific topic, they may need targeted technical support, whether short-term or sustained, on subjects we work with regularly: ISO 13485 QMS overhaul ahead of a notified body audit, risk management under ISO 14971, post-audit non-conformity remediation, post-market surveillance and periodic reporting (PMS, PMCF, PSUR). We carry the technical content; your teams remain in control of the project and their stakeholders.

Recognise your situation

Four moments when our clients call us

No two engagements are alike, but four situations recur regularly. Each situation calls for its own best-suited mode of intervention.

Situation 1 Strategic advisory

Before a CE marking: framing the regulatory strategy

Before a CE marking project mobilises your teams for 12 to 24 months, structural choices must be made: MDR Annex VIII classification, scope of clinical indications, conformity pathway, time-to-market schedule. A vague decision at this stage can cost hundreds of thousands of euros to correct downstream.

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Situation 2 Expert advisory

QMS ISO 13485 overhaul before a certification audit

Your ISO 13485 certification is coming up for renewal, your QMS was built several years ago and has not kept pace with your product changes, or a mock audit has revealed structural gaps. Overhauling it requires external technical support without destabilising the teams already in place.

Situation 3 Expert advisory

Responding to a notified body non-conformity within the imposed deadlines

Your notified body has notified findings following an audit, with a response deadline of 30 to 90 days depending on the nature of the observations. The response requires precise analysis, documented evidence and real remediation. The earlier external support is engaged after notification, the greater the room for manoeuvre.

Situation 4 Operational consulting

Transition between two quality or regulatory managers

Your incumbent leaves before a successor is in place, or your new hire needs a month or two of support to pick up the open files. We hold the role during the transition, document the file status, and accompany the successor's onboarding if you wish.

For obligations specific to your MDR status: Manufacturers · Importers · Distributors · Subcontractors · EC REP →

Our method

Three ways of working in quality and regulatory for medical devices

Depending on your situation, an engagement starts with a diagnostic, with building a deliverable, or with audit preparation. Three distinct entry points, one working method.

00 Diagnostic

Regulatory diagnostic

Establish the facts before committing resources.

Before building an action plan, you need to know precisely where you stand. Document review, targeted interviews with quality and product teams, identification of gaps against the applicable MDR articles and ISO 13485 clauses.

Our commitment

A written, prioritised report that separates what blocks immediately (audit risk, inspection risk) from what can be addressed in a second pass. Our diagnostics run 8 to 25 pages, never 200 unranked Excel rows.

00 Build

Building or overhauling deliverables

Writing what must be documented and justified.

MDR Annex II/III technical documentation, clinical evaluation plan and report (CEP&CER) per Article 61 and Annex XIV of the MDR (MDCG guidance; MEDDEV 2.7/1 rev 4 for methodology), PMS plan and PSUR, ISO 13485 quality procedures: we write or overhaul the critical deliverables that carry your conformity.

Our commitment

Each section is written with its regulatory reference, its justification and its associated evidence. Traceability is built into the drafting, not reconstructed after the fact. We do not deliver a document we could not defend ourselves in an audit.

00 Preparation

Audit and inspection preparation

Working on conformity before it is verified.

Full mock audit, review of available evidence, simulation of auditor interviews, coaching of key contacts. ISO 13485 and MDR audits are not prepared the night before, and competent authority inspections even less so.

Our commitment

We identify the likely questions before they are asked, prepare the answers anchored to available evidence, and review the documents that will be presented. On audit day, your teams discover nothing.

Our working framework

Three commitments that structure our engagements

Beyond the modes of intervention and the subjects addressed, three commitments characterise how we work. They are non-negotiable, because they condition the quality of what we deliver and the trust you place in us.

A certified auditor qualification brought to every engagement

One of the founders works as a certified auditor on ISO 13485 and EU Regulation 2017/745 audits. This regular practice, running alongside advisory engagements, gives us a precise reading of what an auditor is looking for, what they validate, and what they reject. Every deliverable we produce is written with that dual perspective built in.

That dual perspective follows every deliverable we produce.

Honest pricing, calibrated to the actual risk of the engagement

On engagements where scope is stable and unknowns are manageable, we work on a fixed fee. On high-stakes engagements where several parameters remain to be discovered — deep remediation files, complex transitions, Class IIb or III devices with uncertain prior history — we offer a time-and-materials frame or a conditional fixed fee.

No surprises for you, no shortcuts for us.

An integrated offer for manufacturers targeting or operating in Europe

ISOFAC GROUP provides two complementary activities under the same structure: quality and regulatory consulting, and the role of European Authorised Representative for medical device manufacturers established outside the EU. For a manufacturer preparing its entry onto the European market, this means a single point of contact for MDR regulatory strategy, technical documentation construction, and EU representation under Article 11 MDR. Our structure is registered on EUDAMED in this role.

One point of contact for regulatory strategy and EU representation.

Get in touch

One conversation is enough to know if we can help

No sales pitch, no pre-qualification questionnaire. Thirty minutes on the phone with one of the two consultants who would take on the engagement, to understand your situation and tell you honestly what we think.

If the answer is no, we point you to the right resource.

Talk to us

FAQ

Frequently asked questions

The technical documentation is the documented proof of a medical device's conformity with Regulation (EU) 2017/745 (MDR). Its content is primarily defined by Annexes II and III of the MDR and must demonstrate that the device meets the applicable general safety and performance requirements.

Under Annex II, the technical documentation includes in particular:

  • the general description of the device and its specifications;
  • information on design and manufacture;
  • the demonstration of conformity with the general safety and performance requirements (GSPR) of Annex I;
  • the solutions adopted and the results of the risk management referred to in Annex I, Section 3 (generally carried out according to EN ISO 14971);
  • verification and validation data, including preclinical testing, software validation where applicable, and performance data;
  • the clinical evaluation carried out in accordance with Article 61 and Annex XIV;
  • labelling, instructions for use and information supplied with the device.

Annex III supplements this documentation with post-market surveillance (PMS) elements, including the PMS plan, the PMCF where applicable, and PMS reports or PSURs according to the device class.

The technical documentation must be kept up to date throughout the device's lifecycle and made available to notified bodies and competent authorities.

See our Manufacturer Consulting page

Rule 11 of Annex VIII MDR applies to software that is itself a medical device (SaMD). Software intended to provide information used to take decisions for diagnostic or therapeutic purposes is class IIa by default; it is class IIb if those decisions may cause a serious deterioration of health or a surgical intervention, and class III if they may cause death or an irreversible deterioration of health. Software intended to monitor physiological processes is class IIa, or IIb when it monitors vital physiological parameters whose variations could result in immediate danger. All other software is class I. This rule has caused many medical software products to move up in class compared to the MDD. A thorough analysis of the intended purpose is essential before any declaration.

Analyse the classification of your medical software
A clinical evaluation is a methodical, continuous process aimed at demonstrating, on the basis of clinical data, that the medical device meets the MDR's general safety and performance requirements. Governed by Article 61 and Annex XIV of Regulation (EU) 2017/745, supplemented by the MDCG guidance documents (2020-5, 2020-6, 2020-13) and, for methodology, by the MEDDEV 2.7/1 Rev. 4 guidance insofar as it remains compatible with the MDR, it is based on the identification, appraisal and critical evaluation of available clinical data, including scientific literature, data on equivalent devices, post-market data and clinical experience gained after commercialisation.

A clinical investigation, by contrast, is a study conducted on human subjects to generate new clinical data specific to the device. It is required when existing data are insufficient to demonstrate the device's safety, performance or clinical benefit, particularly for certain innovative, implantable or Class III devices.

A clinical investigation may thus constitute a data source within a clinical evaluation, but it does not replace the clinical evaluation itself, which remains mandatory for all medical devices.

Learn more about MDR clinical evaluation
Post-Market Surveillance (PMS) is the system established by the manufacturer to proactively collect, record and analyse data relating to devices already on the market. Governed by Articles 83 to 86 of Regulation (EU) 2017/745 (MDR), it aims to continuously confirm the safety, performance and benefit-risk profile of the device throughout its lifecycle.

The manufacturer must establish a PMS plan proportionate to the risk class and tailored to the type of device. This plan describes the data collection methods: vigilance, complaints, trend analysis, scientific literature, user feedback, post-market clinical data, etc.

The PSUR (Periodic Safety Update Report) is one of the major PMS deliverables:
  • for Class IIb and III devices, it must be updated at least annually;
  • for Class IIa devices, it must be updated at least every two years;
  • for Class I devices, a PMS report is required but not in PSUR format.
The PMCF (Post-Market Clinical Follow-up) is the clinical component of PMS when post-commercialisation clinical follow-up is required to confirm the device's clinical performance and safety under real-world conditions of use.

These obligations apply from the moment the device is placed on the market and must be maintained throughout its period of commercialisation.
EUDAMED is the centralised European database for medical devices. Manufacturer registration takes place in two steps: first, registration of the economic operator (obtaining the SRN, Single Registration Number), then registration of each device with its UDI code. The SRN is assigned by the national competent authority (the ANSM in France). Non-EU manufacturers submit their own registration request; the Authorised Representative, registered in its own name, verifies and confirms that request and the mandate summary, then verifies the UDI and device registrations (Art. 11(3)(c)). Since 28 May 2026, registration of the operator and of new devices in EUDAMED has been mandatory before placing on the market; devices already on the market must be registered no later than 12 months after publication of the Commission notice, i.e. by the end of November 2026.

Prepare your EUDAMED registration with our EC REP service