Hier stellen wir unser Team vor

Unsere Mitarbeiter erreichen Sie über unsere zentrale Telefonnummer oder besuchen Sie die Rubrik Kontakte für die individuellen Email-Adressen unserer Mitarbeiter.

Zentrale Telefonnummer +49 (0)89 4520676-0 | email info@regular-services.com

Andreas Esch-Brödner

Mariam Al Bayati

Consultant

Master’s Degree in Molecular and Cellular Biology

Area of Expertise

CE marking, Technical Documentation, Regulatory Affairs, Quality Management, IVD

Telefon +49 (0)89.45 20 676-0 | email bayati@regular-services.com

Andreas Esch-Brödner

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 Goerlich

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 ibler

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

Telefon +49 (0)89.45 20 676-0 | email ibler@regular-services.com

Hestré Krynauw

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

michael dörffel

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

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

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

alexander popp

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

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

Julia Lorenz

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

Gerhard Willberger

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

Gerhard Willberger

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

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

Liezel Janse van Rensburg

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

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

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