Regulatory Affairs

The regulatory landscape for medical devices governed by Regulation (EU) 2017/745 is constantly evolving and defining. For manufacturers, producers, authorized representatives, distributors, and importers, we offer a range of services to guide your company on the most appropriate path.

 

We will review the available documentation and develop a concrete program that details the activities, necessary resources, and timelines to achieve the objective.

 

• Pre-assessment and precertification audits: identifying areas for improvement at the beginning of implementing a quality management system or technical documentation is essential. These audits provide a comprehensive view of overall compliance with the requirements of applicable standards, laws, and regulations. Therefore, they enable us to prepare an action plan and intervention schedule to reach the goal.
  

• Preparation of technical documentation: targeted consultancy for the review and/or preparation of the technical documentation required by Regulation (EU) 2017/745, in collaboration with company representatives or independently if a complete outsourcing of the activity is required. We will analyze the available documentation and ensure it is clear, complete, and always easily accessible.
  

• Regulatory strategy development: consultation for proper classification and the best certification strategy, identifying the necessary tests to complete the technical documentation in support of the medical device.

• Support for the preparation of the risk management document according to ISO 14971: consultation in planning the activities required to review or produce the risk management document in accordance with international standards ISO 14971:2019 and ISO/TR 24971:2020, or training your team to support them in developing the risk management document.

• Assistance in the registration of Economic Operators and medical devices: we support the company in the proper registration on the EUDAMED portal and prepare the standard procedure and training that will allow the company to operate independently and with awareness of any changes and updates.
  

• Design of Clinical Surveys, Post-Market Surveillance (PMS) and Clinical Follow-up (PMCF) plans: A consultation aimed at preparing a PMS plan that fits the company and the product. A product assessment will lead to planning and assist the company in defining the correct pathway for clinical data collection and evaluation to support the safety, performance, and efficacy of the medical device.
  

• Support in the selection of Notified Bodies and interactions with Competent Authorities: we assist companies in selecting the Notified Body and interact with both the Notified Body itself and Competent Authorities to define, when necessary, the best approach to establish constructive dialogue.
  

• Authorized Representative, Distributor and Importer: these are economic operators with specific obligations and responsibilities. We offer consultancy to enable these categories of economic operators to comply with the specified requirements.

 

Why FTR ADVISOR? Because we take into account the company's context and available resources in designing a regulatory compliance plan.