MARKET ACCESS CONSULTING

Medical manufacturers face challenges in accessing international markets efficiently and safely, while meeting the regulatory requirements of each geographical area.

We offer customized services in order to help you achieve your goals of bringing medical devices to market in a timely and cost-effective manner.

TAILORED SUPPORT FOR MARKET ACCESS

We advise our clients in bringing their medical devices on the market, and/or in accessing new markets,
whether it is a strategic approach to the development of a device or an audit before submission to notified bodies.

TECHNICAL DOCUMENTATION REVIEW

We audit your technical documentation to check its compliance with the EU Medical Device Regulation 2017/745, for the purpose of your CE marking, UKCA or MDSAP.

QMS PRE-AUDIT SERVICE

Our experts perform a tailored assessment prior to the certification audit, whether it is MDR, IVDR or ISO13485. It allows to measure your level of preparation and establish corrective actions.

ADVISORY BOARD

In a collaborative intelligence approach, it allows you to surround yourself with various skills to advise you in your strategy, particularly in strategic analysis and monitoring.

Market access strategy

ACCESSING MARKETS

We have extensive regulatory expertise, particularly in the context of the introduction of your medical devices to the market. This step is crucial and can have major consequences if it is not addressed and mastered effectively.

Contact our team of regulatory experts to discuss how we can help.