INDEPENDENT CONSULTING · MEDICAL DEVICES & DIGITAL HEALTH

Cyrille Gasquères

Regulatory strategy that starts with product strategy

STRATEGY · COMPLIANCE · MARKET ACCESS

I help medical device and digital health teams turn complex regulatory requirements into clear product decisions, credible evidence and practical routes to market. Based in the Toulouse area, working across France and internationally.

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Cyrille Gasqueres

01

Regulatory Strategy

Market access & pathway planning

02

Compliance Management

Audits, gap analysis & remediation

03

Dossier Preparation

Submissions, filings & technical files

04

Authority Liaison

Communication & representation

05

Regulatory Intelligence

Monitoring & impact assessment

20+years in medtech
EU MDRstrategy & compliance
Class I–IIImedical devices
Globalregulatory perspective

About

Senior expertise.
Practical regulatory decisions.

With more than 20 years across medical technology, R&D and regulatory leadership, I help teams make sound regulatory decisions early — when intended purpose, classification, claims and evidence can still shape the product strategy.

My experience combines hands-on technical understanding with senior industry leadership. I work alongside founders, product teams and executives to clarify requirements, challenge assumptions and focus resources on the decisions that matter most.

I hold a Ph.D. in Materials Science and Engineering from the Institut National Polytechnique de Toulouse. My work is grounded in the realities of product development, technical documentation, clinical evidence and lifecycle compliance under the EU Medical Device Regulation (MDR). I work from the Toulouse area with clients in France and internationally.

20+
Years in medtech & R&D
20+
Successful submissions
5+
Client organizations
I to III
Device risk classes

Education

Ph.D. — Materials Science and Engineering

Institut National Polytechnique de Toulouse

Technical foundation

Materials science and engineering

Ph.D. · Institut National Polytechnique de Toulouse

Company

EURL Gasqueres Consulting

Independent regulatory affairs practice

Languages

French · English · German

Professional working proficiency

Services

What I can do
for your organization

From early product definition to market access and post-market obligations, I provide senior, hands-on support tailored to your device, evidence and business priorities.

Regulatory Strategy & Planning

Define intended purpose, classification, claims and target markets early. Build a proportionate regulatory roadmap that connects product decisions, evidence needs, timelines and market access.

Submission & Dossier Preparation

Structure and review EU MDR technical documentation, clinical and performance evidence, risk-management outputs and submission packages so the rationale is clear, traceable and fit for review.

Compliance Audits & Gap Analysis

Identify gaps against applicable requirements, assess their business and compliance impact, and turn findings into a prioritized, actionable remediation plan.

Regulatory Authority Liaison

Prepare for interactions with notified bodies and relevant authorities, align technical positions and support clear, evidence-based responses to questions and findings.

Regulatory Intelligence

Translate changes in standards, guidance and regulatory expectations into concise impact assessments and practical actions for product and quality teams.

Training & Internal Capability

Equip leadership, product, R&D and quality teams to understand regulatory trade-offs, make better early decisions and build sustainable compliance practices.

Approach

How I work

Every engagement follows a structured methodology — because regulatory affairs demands rigor, not improvisation.

D

Diagnose

Understand your product, your markets, and your current regulatory position. Map requirements against your existing documentation and processes.

S

Strategize

Design a regulatory pathway that aligns with your business timeline and risk tolerance. Prioritize jurisdictions and identify critical dependencies.

E

Execute

Prepare submissions, manage communications, and coordinate with authorities. Provide clear status reporting at every stage.

S

Sustain

Maintain compliance through post-market surveillance, renewal management, and continuous monitoring of applicable requirements.

Sectors

Where regulatory strategy makes a difference

My core focus is medical technology, including complex devices and digital health. I can also support adjacent regulated products where the project fits my experience.

Pharmaceuticals & Biotechnology
Medical Devices & Diagnostics
Chemical & Industrial Products
Digital Health & Software as Medical Device

Contact

Let's discuss your
regulatory needs

Planning a new device, preparing for CE marking, reviewing an MDR technical file or addressing a compliance gap? Tell me where you are in the journey and we can discuss the most useful next step.

Email cyrille@gasqueres-consulting.com
Location Toulouse area, France · International projects
Response time A personal reply as soon as possible
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