We support manufacturers in quality and regulatory compliance with confidence, through expert advisory, pragmatic and rigorous technical documentation and complete end-to-end support.
From first strategic decisions to post-market monitoring, Medyxa covers every regulatory step you need to bring compliant devices to market.
Pragmatic, structured guidance to obtain your CE marking and reach the European market with confidence.
Learn moreA tailored roadmap aligning classification, technical file and your business goals within the best timelines.
Learn morePrecise, review-ready technical files built to meet MDR, ISO and Notified Body expectations.
Learn moreA risk-based approach following ISO 14971:2019 to identify, control and re-assess hazards throughout the device lifecycle.
Learn moreDesign, continuous improvement and roll-out of your ISO 13485 QMS, tailored to your organisation.
Learn moreA clear diagnostic of your QMS processes and documents, with an actionable plan to close every gap.
Learn moreContinuous monitoring of French, European, US and other relevant regulatory changes so you always stay one step ahead.
Learn moreFrom design through post-market surveillance, we support you all the way to a sustainable market presence.
Learn moreWe combine regulatory rigour with a hands-on mindset. That is how we help manufacturers move faster without ever compromising on compliance.
A close-knit team of regulatory experts, driven by rigour, curiosity and a genuine commitment to your success.
Qualified Clinical Research Associate (CRA), graduate of a French BTS in Medical Biology Analysis with laboratory experience, specialised in the monitoring of clinical studies.
Founder mentoring and strategic guidance.
Every project follows a proven sequence designed to remove ambiguity, protect your timeline and build confidence with your Notified Body.
We start by understanding your device, its intended use and your current documentation baseline.
Classification, applicable regulations and the most efficient conformity route are defined.
We build or upgrade your technical file, risk management and clinical evidence in a structured way.
A rigorous internal review ensures every requirement is addressed before external assessment.
We coordinate with your Notified Body and support you through the audit and certification steps.
Post-market surveillance, updates and change control keep you compliant year after year.
Wherever safety, quality and market access matter, our expertise adapts to the specificities of your industry.
Class I to Class III devices, from single-use tools to advanced implants.
Connected and interconnected devices, digital health platforms, embedded medical device software and standalone SaMD (Class IIa, IIb, III).
An In Vitro Diagnostic device (IVD) is a product or reagent used to analyse human samples (blood, tissue, urine) outside the body. Diagnostic products are classified from A (low risk) to D (high risk) according to potential harm. Notified Body involvement is required for sterile Class A, B, C and D — approximately 80% of the current market.
Emerging technologies where the regulatory path is still being defined. Includes Annex XVI products of Regulation (EU) 2017/745 (MDR) — products without a medical purpose (aesthetic, wellness) that share characteristics and risk profile with medical devices.
A curated feed of the European regulatory changes that impact medical device manufacturers.
This revision replaces the previous version and updates the interpretation of the classification rules of Annex VIII of the MDR — an essential document to justify your device classification before the Notified Body.
Read the updateThe European Commission continuously updates its official page listing the 2026 harmonised standards decisions under the MDR. An indispensable entry point to check whether your technical standards remain applicable.
Read the updateSince February 2026, compliance with the international ISO 13485 standard is officially mandatory in the United States, replacing the former 21 CFR Part 820 — a major step towards global QMS harmonisation.
Read the updateThe Medical Device Coordination Group clarified how manufacturers should evaluate design and intended-use changes on devices still relying on the MDD/AIMDD certificate.
Read the updateThe European Commission confirmed longer transition timelines for high-risk IVDs, but tightened post-market surveillance and EUDAMED registration duties.
Read the updateActor, UDI/Device and Notified Body/Certificate modules become mandatory in Q4 2025. Preparing your data now avoids costly last-minute filings.
Read the updateA quick primer on European medical device compliance and how Medyxa supports your journey.
Share a few details about your project and we'll come back to you within one business day with an initial assessment.