Dipl.-Ing. Alexandros L. Savvidis

External Consultation for the Mynerva Project of Wyss Center, ETH Zürich, one young start-up Team • Development of one TENS active MD with HARDWARE and SOFTWARE (SiMD) incl. AI Module (Artificial Intelligence) in Neuroengineering Field • QMS and RA Consultation & Supporting Tasks • Checklists for 60601 Standard full Family , 62304 and many other relevants • GSPR , Applicable Standards, Classificaton criteria • Leading the RA and QMS Documentation • FDA and CE Regulatory Pathway Preparations

External Consultation of Bioptron AG, Wollerau & Neuchatel Switzerland • Full Support in Remediation of Audit findings • Capas • Creation of various QA RA Documentation • Full QMS RA Gap Analysis

Full preparation of MDR Technical Documentation and compilation from scratch of QMS, approximately till Sept or Okt 2023, PRRC Responsibilities

Quick Push up for Full Regulatory strategy approach for dental product in the Market as also MDR Gap Analysis for QMS and Product Tech File prepation for project start, PRRC Responsibilities

Full Leading and Executions of QMS Updates for MDR, Update of Processes • Collaboration with Christan Johner Institut GmbH • Coordination Tasks with Tüv Nord • Independent Compilation of New QMS Handbook • Independent Compilation of MDR Tech Files for dental Products Class IIA • Independent Compilation of Regulatory Strategy for Company Products • Managing Internal & External Audits with SQS

Remote Contract Role by Customer in Switzerland - Compilation of one full internal Process for the Discontinuation as End of Life of one Medical Device which has been sold in 70 Countries across the globe - Compilation of Flow Diagrams - Gap Assessment on Quality Management Book for MDR Compliance - International Regulatory Research for Ventilators as Medical Devices - Analysis of Versions Update of Applicable Standards for Ventilator Class II - Essential Requirements Checklist Comparison IMDRF GHTF

- Compilation/Review/Approval full MDR Tech Files for Medical Products Class I, ΙΙb, ΙΙΙ - Organisation of MDR Transition Activities - Support 510K Submissions, orthopedical implants, active & non- active - Compilation of FDA Distributor- Supplier Agreements - Support Certifications in Australia and Taiwan - Compilation of Regulatory Pathways - Coordination with Notified Bodies, Authorities, US Agents - Supporting New Business Development and Quality

Technical Files MDR Changes, for Surgical Power Tools • Updating Clinical Evaluation Reports , • Norm Checklists • Literature Research for Power Tools, Osteotomy • Compilation DCRM Reports Plans, Plans, Reports • Updates Instruction for Use, Reprocessing Guidlines, Labelling • Product Sales and Complaints Analysis, • Compilation Usability Engineering File • Definition of Lifetime, Definition Key Function Elements, • UDI, Redlines Technical Drawing • Verification /Validation Reports

• Definition of the Preparation Process of Technical Files for Medical products Certifications • MDR Updates for already existing Tech Files • Consulting Support in internal Documentation

Development of Pharmaceutical Packaging, Responsible for the development of the product documentation (technical dossier for each product category; Site Master File)

CE Certification of the Patient Transport Unit of Lufthansa with LHT and TÜV Süd Germany. Generation of complete Technical File, DHF of existing CE medical Products, stretchers, retainers of devices, gas installations in helicopters and airplanes. Definition of SOP`s for the Ce Marking, Generation of Post Market Surveillance, Design Changes, Internal Audit

Kontrolle von Design History Files . Risk Management von Design- Merkmale . Verantwortlich für die Gestaltung und Bearbeitung von Implantaten und Instrumenten . . Generation oder Updates von Design History Files für das Produkt. Import von technischen Zeichnung ins Siemens Unigraphics NX von CAD Solid Works.

Educational Trainings bei BSI Group Deutschland in Germany und in Uk für CE Marking Process for Medical Devices und for Leading and Implementation of Audits according to EN ISO13485 by medical devices manufacturers.

Performance Reports, Durchführung des Dokumenten Reviews der Service Reports GxP(GDP/GDocP), Prozessoptimierung Enterprise Management Systems (EMS):u.a. 6Sigma Prüfungen, KPI Review, 6S Auswertungen, Bearbeitung von Product Complaints, CAPA Dokumentation, Arbeit mit SDLC (Life Cycle Management ), Good Manufacturing Practice GMP für PD Geräte, PD Hardware Reparaturen,Organisierung vom Ersatzteilebestand

Befristeter Jahresvertrag fuer die Position des Krankenhausplaners, EDV Planung von Endoskopie Turmen, chirurgischen Instrumenten, Consumables, OP Geraete u.s.w fuer gewisse Krankenhausprojekte in Turkmenistan

Befristetes Projekt : Aktualisierung von technischen Dateien von chirurgischen Instrumenten der Klasse I für B | BRAUN Aesculap nach den neuen Standards Risikoanalysen, FMEA, DHF, CER, klinische Auswertungen durch Produktbeschwerden, Literatur, pub med, Elsevier, Biokompatibilität, Lieferantenkontrolle, Prüfpläne, Etikettierung, Verpackungspezifikationen, Stucklisten, technische Zeichnungen in SAP, Sterilisationsvorschriften Professionelle Koordination mit RA und F & E von Aesculap.

Hybrid Funktion in Produktmanagement und im Vertrieb von medizinischen Produkten. Hämostase Pulver, Chirurgische & Urologische Gewebenetze, Stents,Baloon Katheter, bioresorbierbare Filmen, Weichgewebe-/KnochenBiopsien, Orthopädische Implantate. Schulungen vom Personal, Präsentationen von Produkten, Kontakt mit Hersteller, Verwaltung der Produktstudien, Referenzen und Verkaufsbroschuren der Firma. Qualitative Vergleiche von neuen Produkten.

Vertriebsunterstützung von medizinischen Geräten, Beobachtung von öffentlichen Ausschreibungen für Gross-/Κleingeräte in Krankenhäusern inklusive Vorbereitung von Unterlagen und Dokumenten. Produktreklamationen bearbeiten, Kontakt mit Hersteller Vertrieb, Service, Berchtold , Medela, Integra,Bowa, Emed, OP Tische, Beleuchtung, Zubehör, Greggersen Gastechnik, Casmed Monitoren, u.v.a.) sowie Stillenprodukte (Medela CH)