Medtech

In the European Union, bringing medical devices to market necessitates obtaining a CE Marking, an indicator of a product’s compliance with EU regulation. The regulation meticulously define the safety and performance criteria applicable to medical devices within the EU.

A core part of the process of medical device CE marking is the preparation of the technical documentation and the establishment of a Quality Management System by the manufacturer.

RPN guides and supports medical device manufacturers throughout the process of obtaining and maintaining a CE mark in accordance with the European Medical Devices Regulation 2017/745 (MDR).

The regulatory and medical writing support include services such as:

• Identification of the relevant EU requirements.
• Technical Documentation Gap Analyses for compliance with MDR requirements
• Classification determination.
• Contacts with Notified Bodies and assistance in the conformity assessment process for CE markings.
• Preparation of the Technical File.
• Declaration of Conformity for the Medical Device.
• Usability testing in accordance with the IEC 62366 standard.
• Development of clinical evaluation documents (Clinical Evaluation Plan – CEP and Clinical Evaluation Report – CER).
• Design, Development and Validation documentation.
• Development of the Biological Evaluation Plan (BEP) and Report (BER) for biocompatibility assessment of medical devices.
• Contacts with qualified laboratories for device testing.
• Implementation or update of the Quality Management System.
• Preparation of Risk Management files.
• Selection of a European Authorized Representative, if necessary.
• Appointment of a Person Responsible for Regulatory Compliance.
• Internal audit of the Quality Management System and Technical File.
• Review of labels and instructions for use.
• Submission to the Notified Body.
• Post-market surveillance management: preparation of Post-Market Surveillance (PMS) plan and report, Periodic Safety Update Report (PSUR), Post-Market Clinical Follow-Up (PMCF) plan and report.

Our expertise serves companies of various sizes, including:

• Multinationals facing challenges with Notified Bodies, CAPA systems, global registration resources, technical file maintenance, Clinical Evaluation Report preparation, Person Responsible for Regulatory Compliance (PRRC), PMCF, and Risk Management.
• SMEs seeking additional resources and hands-on expertise for product development and international regulatory compliance.
• Startups grappling with regulatory demands and in search of a partner capable of assisting with compliance issues, from strategic planning to market approval.