MedConCap GmbH competence team

Anette Skowronsky – Managing Director
- Pharmacist
- 1st and 2nd party auditor EN ISO 13485:2016
- Risk management according to EN ISO 14971:2019
- Implementation of MDR
- Evaluation of boderline products medical devices-pharmaceuticals-cosmetics
- Strategic consulting for the Management
- Highly experienced speaker and facilitator of face-to-face and online seminars

Dr. Christine von Reibnitz
- Health scientist
- Expert on reimbursability of medical devices in the outpatient and inpatient sector
- Development of training concepts, classroom training, online seminars and e-learning
- New Work, Agile Working
- Conducting clinical studies for medical devices

Susanne Mays
- Quality Management
- QMB (certified by TRLP) according to DIN EN ISO 9001
- Internal auditor according to DIN EN ISO 13485
- Many years of experience in the medical device sector (Class I and II)
- Coach (certified)
- Auditor (certified)
- Speaker
- Trainings
- Mediator (cert. Univ.)
- Project Management (TRLP)
- Time Management

Dr. Petra Hertel
- Chemist
- Quality auditor DIN ISO 9001:2015
- Internal auditor according to ISO 13485:2016
- Implementation of the MDR (GAP analysis, BEP, BER, TD, PMS and PMCF)
- QMS according to ISO 13485:2016
- Responsible person according to Article 15 MDR
- Supplier management and audit in accordance with DIN ISO 13485: 2016
- Many years of experience in R&D, production and quality control, including Testing techniques for medical devices (class I and II)

Gerhard Kammerlander
MBA, academic BO, DGKP, AZWM®
- ZWM®-CertifiedWoundManager on the basis of §64 GuKG
- CEO – Akademie-ZWM AG (Certified Wound Management) – Embrach/Zurich, Switzerland, ISO 9001, ISO 29990
- First European wound management training center with ISO & EN certification
- CEO – Akademie-ZWM GmbH (Certified Wound Management) – Linz, Austria, ISO 9001, ISO 29990, EN 15224 certified
- CEO – WKZ- WundKompetenzZentrum® GmbH-Linz – Austria & Embrach/Zurich – Switzerland; ISO 9001, ISO 29990, EN 15224 certified
- First European WKZ-WundKompetenzZentrum® with ISO 9001, ISO 29990, EN15224 certification
- President ARGE (Working Group) ZWM® Certified Wound Managers (German-speaking Europe)
- Official, authorized TUEV AUSTRIA examiner for ZWM® Certified Wound Management and AHW®/WZ®/WKZ®/PELLEGRINUS®

Stefan Bergmann
- Project management
- Long-standing project manager with experience in international projects in the medical and medical technology sector
- Cooperation with national and international wound centers and clinics in the area of training
- Establishment of wound centers and development of curricula for training in the wound area.
- Networker and communications fan
- Specialist areas: digital applications for clinical studies, wound documentation and training.

Dr. med. Alper Erkin
- Clinical evaluations, clinical studies, data analysis, biostatistics and accompanying scientific research
- Specialist in cardiac surgery and wound specialist.
- Head of the Department of Cardiac Surgery and Director of the Wound Clinic at Sakarya University, Turkey.
- Lecturer at Sakarya University
- Numerous publications in the field of wound care.
- Wound healing and wound care
- Implementation of clinical studies
Fredi Skowronsky
Data manager and data protection officer, IT officer.
You can find an overview of the entire MedConCap team summarized in an overview for download: