Ing. Evangelos Tavandžis-QMD

Ing. Evangelos Tavandžis-QMD

Ing. Evangelos Tavandžis-QMD

  • Headquarters: Klukovická 1530/8, CZ 155 00 Praha 5
  • ID no.: 69833249
  • Tel.: +420 603 305 791
  • E-mail: tava@iol.cz
  • Ing. Evangelos Tavandžis-QMD

Competent Profile

  • 1988-1991: pioneers in the field of approval of active medical devices in the state enterprise Zdravotnické Zásobování under the responsibility of the Ministry of Health, in the position of research and development worker
  • 1992-1999: approval of medical devices at the State Institute for Drug Control (SUKL) - in the position of bioengineer and then Head of Department of active medical devices
  • 2000-2004: inspections of medical devices , vigilance, clinical evaluation and clinical trials in SUKL, in the position of the Head of Medical Devices Branch
  • 2000-04 / 2017: conformity assessment according to MDD 93/42 / EEC (CE) and ISO 13 485 in the position of the Lead Auditor( Medical Device Expert for the Norwegian Notified and Certification Body DNV (Presafe) covering all medical devices risk classes (I, IIa , IIb, III)
  • 2001-2003: TUV Rheinland, Germany – Certification and Notified Body for MDD 93/42 / EEC and EN ISO 13485 for Medical Devices as Lead Auditor / Auditor
  • 1998-2003: ČIA, (Czech Accreditation Association) PRAHA, Standards Committee in the field of QMS - accreditation according to ČSN EN ISO 13485: yyyy, in the position of external evaluator of ČIA
  • 2017- to date: ISO 13 485: 2016 Lead Auditor for Lloyd's Register, CZ + UK

Business profile

  • Consulting area: PRACTICAL Consultation on the implementation of new MDR (Medical Devices Regulation) requirements and ISO 13 485: 2016 (e.g risk management, clinical assessment, usability, PMS, PMCF, Annexes I, II, III, IX MDR ...) preparation ie. "Smart Technical File " (© STF "Smart TF")
  • Auditee area: PRACTICAL pre-audits according to MDR requirements and ISO 13 485:2016 , i.e. "Mock audits" for unannounced audits, Vigilance, internal auditing by an external auditor ISO 13 485:2016
  • Training area: PRACTICAL trainings / workshops implementation of new MDR requirements and ISO 13 485: 2016, risk management, clinical assessment, usability, PMS, PMCF, Annexes I, II, III, IX MDR ...
  • Area gap analysis:3 DAY PRACTICAL to identify the state of readiness for new MDR requirements and to prepare for a specific "Road Mape" for implementation
  • Regulatory Area: PRACTICAL support of a regulatory person in the field of implementation of new MDR requirements or implementation of "as external regulators of affairs"