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Flavia Russo

Atty at Law
Quality Compliance Officer

  • Meditrial Srl
    Via Po 9
    Rome, Italy
    Ph. +39 06 45429780 – Fax. +39 06 45429781
  • I started at Meditrial as a trainee several years back and am now proud to be effectively involved in the Company’s Quality Management System and SOPs. It is an ever challenging task but after our recent ISO 27001 certification I can also definetely say, very rewarding.
Flavia Russo, Atty at Law

Ms. Flavia Russo is an attorney with an in-depth understanding of the European Medical Device Regulation and the International Organization for Standardization (ISO). At Meditrial Europe, as a Quality Compliance Officer, she is involved in a wide range of activities ensuring the maintenance and upkeep of Meditrial’s quality system. She is also involved in contract management for Meditrial as European Authorized Representative guaranteeing compliance with the new MDR 2017/745/EU.

Education

  • 2010 Master’s Degree in Law at La Sapienza University in Rome
  • 2015 State Attorney's Examination Degree District Court of Appeal, Rome, Italy
  • 2015 Diploma of the Specialization School for Legal Professionals University “La Sapienza”, Rome, Italy
  • 2017 ISO 9001 Internal Auditor Certificate - CEPAS, Rome, Italy
  • 2017 Post-graduate Master Course in Quality “Expert in quality management systems - Quality Insurance - Environment - Energy” Uniform, Rome, Italy
  • 2019 Executive Program in Privacy Governance Luiss Business School - Rome, Italy
  • 2019 Executive Program in Compliance Management - Luiss Business School - Rome, Italy
Languages English, Italian

Achievements

  • Drawing up of the documentation necessary to ensure compliance with EU-GDPR (2016/679)
  • Creation of a series of training tutorials on new European Regulation on medical devices (MDR 2017/745/EU) for Device Manufacturers and clinical study Sponsors
  • Contribution to the creation of Meditrial Information Security Management System which gained the ISO27001:2013 certificate of conformity in October 2019
  • Review and update of Meditrial Quality Management System documents and preparation for annual ISO9001:2015 audit

Career

  • 2015/2017 Freelance Laywer
  • 2013 Collaboration with a Law firm of Attorney Francesco Paolantonio, Rome, Italy Practicing criminal law
  • 2010/12 Attorney Trainee at a Partner’s Law firm in Rome. The training was focused on: Criminal law and company law, Editing of defenses

Skills and Engagement

  • Reviewing contracts for Meditrial as European Authorised Representative in order to make them compliant with the new MDR 2017/745/EU
  • Gap analysis between previous and current European and International Regulation on Medical Devices
  • Supporting clinical study Sponsors in Management of audits/Inspections
Tutorial preparation for:
  • The highlight the new rules in the new European regulation for medical devices
  • The new Meditrial personal training (company tools, external communication policy, confidentiality breach and data policy

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