Thanga Bhuvanesh

• Lead contributor towards Notified Body interactions including end-to-end conformity assessment under EU MDR, technical documentation review dialogue, deficiency responses, and surveillance audits, contributing to full technical documentation submission within 90 days. (for Class IIa product) • Regulatory representative for cross-functional teams and external product partners, translating quality and regulatory requirements into practical guidance for R&D, Quality, and commercial stakeholders, and coordina

• Manage EC/CA submissions, ensuring compliance with regulatory requirements, relevant legislation, and agreements with the sponsor. • Serve as primary point of contact for sponsor on EC/CA requirements and regulations for the countries within European Union. • Achieved timely EC/CA submissions through effective coordination and management. • Maintain effective and prompt communication with the sponsor, study start-up specialists, and external vendors. Manage EC/CA submissions, ensuring compliance with r

• Preparation of Clinical Evaluation Reports (CER) und Clinical Evaluation Plans according to MDR und MDD • Assessment of inputs from technical documentation prepared in accordance with EU MDR, ISO13485, ISO14971 for Oral, Respiratory and SaMD products • Evaluating and summarizing clinical evidence including data from sources such as pre/post market clinical investigations, scientific/clinical literature, post-market surveillance, risk management reports, and biocompatibility testing, bench testing. Analyzi

• Conduct literature searches (Pubmed, Cochrane) to collect clinical data for medical devices belonging to different therapeutic areas • Drafting and reviewing CERs (including SaMD), classified as Class I, IIa und IIb under the new EU MDR • Significant impact: Optimisation of the search protocol for adverse reactions in databases and improvement of efficiency by 30%

• Project manager: Development of new concepts for the production of material surfaces for regenerative medicine. Publication of new scientific journal articles. • Science communicator: 2017 first place for presentation at Helmholtz Centre; 2015 second place for poster presentation "Advanced Functional Polymers for Medicine"-Conferenz in Galway, Ireland

Trainings 1. Post-market surveillance activities 2. SaMD 3. Cybersecurity

I am really enjoying this python course. I am learning this course to understand how programmers think and create high quality software and apps. Current percentge complete: 60%

Joint Master programme hosted by Free University Berlin, Humboldt-University Berlin, Technical University Berlin and University of Postdam