Hier stellen wir unser Team vor
Unsere Mitarbeiter erreichen Sie über unsere zentrale Telefonnummer oder E-Mail-Adresse.
Zentrale Telefonnummer +49 (0)89 4520676-0 | email info@regular-services.com
Die individuellen E-Mail-Adressen unserer Mitarbeiter finden Sie hier:
Mariam Al Bayati
Consultant
Master’s Degree in Molecular and Cellular Biology
Area of Expertise
CE marking, Technical Documentation, Regulatory Affairs, Quality Management (ISO 13485, 21CFR820), In-vitro-Diagnostika
Telefon +49 (0)89.45 20 676-0 | email bayati@regular-services.com
Andreas Esch-Brödner
QM Documentation Specialist and Assistant
Sales & Marketing
Area of Expertise
Quality Management (ISO 13485, 21CFR820), Technical Files for CE-marking, Customer Support
Telefon +49 (0)89.45 20 676-0 | email esch-broedner@regular-services.com
Tanja Görlich
Consultant
Clinical Evaluation
Area of Expertise
Clinical Evaluation Reports according to MEDDEV 2.7.1 and European Regulation 2017/745 (MDR). International Post-Market-Surveillance Reports
Telefon +49 (0)89.45 20 676-0 | email goerlich@regular-services.com
Robert Karl Ibler
Senior Consultant
Master´s Degree in Physical Engineering
Area of Expertise
CE marking, Quality Management (ISO 13485, 21CFR820), European Directives,
European Guidance Documents and Standards, Author of Feature Publications in all areas of European Medical Device Regulation
European Guidance Documents and Standards, Author of Feature Publications in all areas of European Medical Device Regulation
Telefon +49 (0)89.45 20 676-0 | email ibler@regular-services.com
Hestré Krynauw
Graphic Design and DTP specialist
Area of Expertise
Feature Publications in all areas of European Medical Device Regulations, Translations, Power Point Presentations, Video-Story-Boards
Telefon +49 (0)89.45 20 676-0 | email krynauw@regular-services.com
Thomas Ceferino Kutschenreiter
Managing Director | Senior Consultant
Graduate Engineer Applied Science in Engineering Physics
Area of Expertise
Statistics, Process Validation, Quality Management
Telefon +49 (0)89.45 20 676-0 | email kutschenreiter@regular-services.com
Julia Lorenz
Managing Director | Senior Consultant
Master´s Degree in Industrial Engineering
Area of Expertise
CE marking, Quality Management (ISO 13485, 21CFR820), European Directives, European Guidance Documents and Standards, Clinical Evaluation, Post-Market-Surveillance
Telefon +49 (0)89.45 20 676-0 | email lorenz@regular-services.com
Jürgen Loy
Head of Communications
Area of Expertise
e-learning, How-Casts, Edu-Casts, 3D-Animation, 3D-Rendering, Communication
Telefon +49 (0)89.45 20 676-0 | email loy@regular-services.com
Dr. Barbara Malitschek
Senior Consultant
Degree in Molecular Biology (Dr. rer. nat.)
Area of Expertise
Biological Evaluation, Technical Documentation, UDI, Regulatory Affairs
Telefon +49 (0)89.45 20 676-0 | email malitschek@regular-services.com
Alexander Popp
Senior Consultant
Master´s Degree in Mechanical Engineering
Area of Expertise
CE marking, Quality Management (ISO 13485, 21CFR820, Ordinance 169), European Directives, European Guidance Documents and Standards Regulatory specialist EEA, USA, South America, Australia, Asia
Telefon +49 (0)89.45 20 676-0 | email popp@regular-services.com
Andreas Schlichting
Consultant
Diploma in TQM and Computer Science
Area of Expertise
Software for Medical Devices, Technical Documentation, Quality Management
Telefon +49 (0)89.45 20 676-0 | email schlichting@regular-services.com
Robin Stock
Consultant
Master’s Degree in Biomedical Management and Marketing (M. Sc.)
Area of Expertise
Risk Management, Clinical Evaluation, Post-Market-Surveillance, Technical Documentation, Agile Project Management (Scrum)
Telefon +49 (0)89.45 20 676-0 | email stock@regular-services.com
Franziska Tretter
Consultant
Bachelor`s Degree in Technical Writing/ Technical Communication (B. Eng.)
Area of Expertise
CE marking, Quality Management (ISO 13485, 21CFR820), Technical Documentation, Terminology, Usability, Translations, Power Point Presentations
Telefon +49 (0)89.45 20 676-0 | email tretter@regular-services.com
Liezel Janse van Rensburg
Consultant
Clinical Evaluation
Area of Expertise
Clinical Evaluation Reports according to MEDDEV 2.7.1 and European Regulation 2017/745 (MDR). International Post-Market-Surveillance Reports
Telefon +49 (0)89.45 20 676-0 | email jansevanrensburg@regular-services.com
Alison van Schoor
Consultant
Clinical Evaluation
Area of Expertise
Clinical Evaluation Reports according to MEDDEV 2.7.1 and European Regulation 2017/745 (MDR). International Post-Market-Surveillance Reports
Telefon +49 (0)89.45 20 676-0 | email schoor@regular-services.com
Hans-Peter Wettl
Senior Consultant
Master`s Degree in Electrical Engineering
Area of Expertise
CE marking, Quality Management (ISO 13485, 21CFR820), 510(k)-Clearance, European Directives, European Guidance Documents and Standards, Author of Feature Publications in all areas of European Medical Device Regulations
Telefon +49 (0)89.45 20 676-0 | email wettl@regular-services.com
Gerhard Willberger
Consultant
Business Administration
Area of Expertise
CE marking, Quality Management (ISO 13485, 21CFR820), Author of Feature Publications in all areas of European Medical Device Regulations, Translations, Power Point Presentations
Telefon +49 (0)89.45 20 676-0 | email willberger@regular-services.com