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services & expertise

What can I do for you ?

Developing a medical device requires rigor, structure and regulatory expertise.
I support manufacturers in building robust quality systems, securing development activities and passing audits with confidence.
From design to market access, regulatory requirements are embedded directly into your processes.

My goal is to turn compliance into a driver of performance and reliability.

Hiring me brings instant expertise, flexibility and focus.

You get the right level of compliance support exactly when you need it – no overhead, no delays, just confidence to move faster to market.

Let's work together !

Medical device compliance lies at the intersection of multiple critical requirements.

This diagram illustrates how conformity expertise connects standards, processes and product challenges.

CONFORMITY EXPERT EN ISO 13485 EN ISO 14971 EN 62366 EN 62304 QUALITY SYSTEM PROCESSES PRODUCT LIFE CYCLE USABILITY & CLINICAL PERFORMANCE RISK & SAFETY

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Medical device compliance lies at the intersection of multiple critical requirements.

This diagram illustrates how conformity expertise connects standards, processes and product challenges.

CONFORMITY EXPERT EN ISO 13485 EN ISO 14971 EN 62366 EN 62304 QUALITY SYSTEM PROCESSES PRODUCT LIFE CYCLE USABILITY & CLINICAL PERFORMANCE RISK & SAFETY

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Details will appear here.

let's work together

This timeline illustrates the key stages of a product development project and highlights where my expertise creates the most value.

Hover over each milestone to discover how my compliance support strengthens your project at the right moments.

YOUR PROJECTMY CONTRIBUTION Project Initialization Concept Definition My impact :My role :Feasability assessment Classification of the deviceWhy ? :An early guidance secures strategic decisions and prevents costly redesigns later in the project. Requirements' Definition My impact :My role :Regulatory Strategy & Roadmap Alignment with Business ObjectivesWhy ? :Structuring a clear strategy provides consistency between intented use, standards and development activities. Design Architecture My impact :My role :Establishment of quality and risk management processesWhy ? :Risk and usability directly impact design choices, test strategies and regulatory acceptance. Prototype Iteration My impact :My role :Design Inputs Risk management Plan (ISO 14971) Usability Framework (EN 62366-1)Why ? :Technical decisions can silently introduce non-compliance or future certification blockers. Verification Testing My impact :My role :Validation of regulatory robustness Usability evidence Clinical rationale Why ? :This phase must not assume, but demonstrate compliance. Weak justification leads directly to audit findings or rejected submissions. Conformity Assessment My impact :My role :Compilation of technical files Conformity assessment Interactions with notified authoritiesWhy ? :This is where all previous decisions are judged. Inconsistencies become visible and costly. Industrialization Market Deployment My impact :My role :Regulatory approval CE marking or market authorization Readiness for industrializationWhy ? :A rigourous involvment at this stage can greatly reduce time-to-market while securing a robust long-term compliance of the product. Lifecycle Management My impact :My role :Maintaining compliance Managing changes Regulatory updatesWhy ? :Poorly managed changes can invalidate certification or trigger regulatory actions.

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