Market access for medical devices requires a well-defined approach, beginning with an in-depth analysis of your product and its specific features. We support you in developing a personalized market access strategy, tailored to local and international regulatory requirements while considering the unique characteristics of your innovation and development strategy.

➜ Detailed Expertise Report on the Applicable Regulatory Framework

We provide a comprehensive analysis of European regulations (MDR, IVDR), ISO standards, and market-specific regulations (USA, Asia, etc.), offering a clear understanding of the requirements your product must meet.

➜ Strategic Elements for the Development of Your Innovation

We identify the strategic levers necessary for the introduction and growth of your product in various markets. This includes assessing potential risks, market opportunities, and regulatory authorities' expectations.

A Thoughtful Process to Secure the Regulatory Strategy for Your Medical Device

Definition of the Class and Type of Medical Device

Defining the scope of applicable requirements

Developing a strategic roadmap

Matrix-based approach for a comprehensive view of the innovation

Support in preparing regulatory submissions

Monitoring and adjustments according to evolving requirements

➜ Definition of the class and type of medical device

We begin with an in-depth analysis of your innovation to precisely determine the class of the medical device according to the European MDR 2017/745 and IVDR 2017/746 regulations. This classification not only establishes the level of risk but also defines the applicable regulatory requirements, necessary studies, and timelines for validation processes.

➜ Defining the scope of applicable requirements

Once the device class is determined, we identify all relevant regulatory requirements to be applied throughout the product's lifecycle. This includes technical, clinical, quality, and risk management requirements, as well as those related to international market entry (based on the desired export countries).

➜ Developing a strategic roadmap

We create a detailed roadmap outlining the key stages of your product’s development, the requirements to be met, and the timeline for market entry. This roadmap provides a clear overview of all the processes necessary to achieve compliance and ensure optimized and secure market access.

➜ Matrix-based approach for a comprehensive view of the innovation

To provide maximum visibility on regulatory challenges, we adopt a matrix-based approach. This method cross-references regulatory requirements, risks, and opportunities for the various target markets. You gain a global and precise understanding of the steps to follow, resources to allocate, and timelines to anticipate.

➜ Support in preparing regulatory submissions

Once the roadmap is established, we assist you in preparing all necessary documents for certification applications, clinical investigations, and procedures to obtain CE marking, FDA approval, and other international certifications. We also guide you in structuring data to optimize the technical file and facilitate its approval.

➜ Monitoring and adjustments according to evolving requirements

The regulatory framework can evolve due to new European directives or changes in international legislation. We ensure continuous monitoring and help you adjust your strategy in line with new requirements to maintain your product's compliance over time.