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
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"
