Project management for the transition of the entire portfolio to the EU MDR, primarily Class 3 and Class 2 products. Preparation of technical dossiers. Conducting gap analyses and identifying necessary derived actions. Overseeing suppliers and conducting supplier audits. Identifying and managing external service providers. Establishing and improving processes. Supporting employees to enhance performance. 

Registration of IVDs for personalized medicine, including related topics, in EU and non-EU countries. Conducting supplier audits. 

EU-MDR Transition of ophthalmologic and refractive products; Registration of ophthalmologic and refractive products in the CIS and EMEA region; Enterprise-wide improvement of the change management process; Development and implementation of a reporting process for CIS and EMEA countries. Processing CAPAs and nonconformities. Creating and revising pFMEAs. 

Gap analyses in accordance with the EU MDR and EU IVDR for numerous technical files. Due diligence activities in connection with the acquisition of medical devices as a legal manufacturer. 

Development of a customized QMS in accordance with ISO 13485, followed by its implementation for an IVD startup. 

Development of a customized QMS in accordance with ISO 13485, followed by its implementation for a heart pump startup. 

Redesign of core QMS processes for an IVD manufacturer to improve effectiveness, ensure compliance, and centralize operations. 

Development of a customized QMS in accordance with ISO 9001, followed by its implementation within the company. 

Development of Post Market Surveillance Process to achieve compliance with EU IVDR. Creation of a IVDR Performance Report. 

Development of a customized QMS in accordance with ISO 9001, followed by its implementation within the company. The client continues to receive support today with conducting internal audits and assistance with notified body audits.