In today’s complex regulatory landscape, obtaining CE marking is a strategic journey that requires precision and careful planning to meet legal obligations. To support companies through this process, ECM offers Structured Dialogue, a well-established service the body has provided for years. This approach was developed to address the need for clear communication between the manufacturer and the Notified Body, ensuring a smooth process free of uncertainties.

EFFICIENCY AND PREDICTABILITY OF THE PATHWAY

The main advantage of Structured Dialogue lies in its ability to significantly enhance the efficiency and predictability of the entire compliance process. Throughout all project phases, structured dialogue allows for the anticipation of potential critical issues, while always maintaining full respect for the independence and impartiality that characterize the Notified Body’s operations. This is not a consultancy service, but a technical discussion aimed at clearly defining expectations and procedures.

AREAS OF APPLICATION AND SUBJECT MATTER

Structured Dialogue is a versatile tool that can address various pillars of the certification process. Key topics that can be explored in detail include:

• Procedural aspects and timeframes: a focus on the application stage and Notified Body procedures

• Regulatory requirements: analysis of the applicable regulations and guidelines, qualification and classification.

• Assessment procedures: detailed overview of the certification routes implemented by the Notified Body.

• Modular approaches: management of strategies integrating clinical, technical, and regulatory requirements for compliance.

HOW TO ACCESS THE SERVICE

Companies interested in streamlining their path to certification can request a Structured Dialogue directly from ECM.

Contact our Sales Managers:

• Diego Stevanella diego.s@entecerma.it (+39) 393 2471040

• Marzia Pellegrini marzia.p@entecerma.it (+39) 392 0710386