Co-founder and Board Member

• Connecting Regulatory Affairs Professionals
• Facilitating Regulatory Exchange

Associate Lecturer

• Clinical Evaluation
• State-of-the-Art Evaluation

Founder & Owner

• Clinical Evaluation Consulting
• PMS/PMCF Consulting
• Clinical Development Planning
• Regulatory Affairs Consulting
• Clinical Data generation

Freelance Consultant – Projects

• Clinical Evaluation process for external service provider
• Clinical Evaluation process for CRO
• Regulatory Strategy and Clinical Evaluation according to MEDDEV 2.7.1 for a resorbable medical device
• Regulatory Strategy for coated stent
• Risk Management consultant for manufacturer of dialysis products (leading global harmonization of Risk Management process with interface to
• Clinical Evaluation process)
• Regulatory Strategy for pharmaceutical application device
• Risk Management for HF surgical device
• Interim Risk Manager and team lead (Disposables for heart-lung machines; Update of 35 risk management files; Implementation of Risk Management tool)
• Clinical Evaluations according to MEDDEV 2.7.1 for orthopaedic implants
• Biological Safety Evaluation according to DIN EN ISO 10993-1 for orthopaedic implants
• Regulatory Strategy for surgical instruments for orthopeadic implants
• Regulatory Strategy and complete Technical Documentation for CE mark for mobile organizational units

Head of Regulatory Affairs

• Responsible for all CE-marked medical devices (non-active) of SFM
• Responsible regulatory affairs contact person for OEM clients from medical device and pharmaceutical industry
• Responsible for update of all technical documentations
• Process optimization for risk management
• Implementation of clinical evaluation and usability engineering processes, as well as standardized procedures for preclinical testing
• In-house training of colleagues in regulatory affairs topics
• Strongly involved in implementation of document management system for the whole company
• Demarcation between drugs and medical devices – Presentation at University of Applied Sciences in Ansbach, Germany
• RAPS Online University student in dual course for pharmaceuticals, medical devices & combination products (US and EU regulations)
• Speaker at conferences and seminars on Regulatory & Clinical Affairs (e.g. Forum Institut, BVMed)
• Speaker at Medica/Compamed 2013 on Safety Protection Devices
• Member of BVMed working team Regulatory and Political Affairs
• Member of DIN working groups for quality management and risk management standard

Functional Head Non-active medical devices and Clinical Affairs

• Responsible Manager for Clinical and Preclinical Affairs with a team of three employees and more than 15 freelance partners
• Responsible for Clinical Evaluations according to MEDDEV 2.7.1 (Rev.3) for more than 100 different products of more than 50 different manufacturers
• Clinical Evaluation and Drug Delivery Devices – In-house training and training in cooperation with Forum Institut and APV
• Planning of Clinical Investigations according to EN ISO 14155 in cooperation with freelance partners
• Biological Evaluations according to DIN EN ISO 10993-1 and coordination of tests with external labs
• Technical Documentation, responsible for compilation of 20 technical files for joint implants (higher classification)
• Expert statements concerning demarcation questions for medical devices and medicinal products
• Summary Technical Documentation according to GHTF guidance
• Review of 510(k) for active medical device
• Support for reimbursement questions in Germany (G-BA and Hilfsmittelverzeichnis)
• ISO 13485 Training, including QMB, internal auditor and third party auditor
• Responsible for sales and acquisition for clinical evaluations and related topics
• Strongly involved in business development of Yes Medical and interface to Yes Pharmaceutical Development Services (mother company)
• Partly responsible for content of company website and for online marketing of the site

• Technical Documentation, compilation of 35 technical files for class I, IIa and IIb medical devices
• Risk Analysis, Risk Management, DIN EN ISO 14971
• Project management and coordination of a project including 15 team members and including communication with external partners on behalf of the client

Development Engineer

• Product development: remittance work and in-house development
• Patent and literature research, preliminary tests and conceptional development, product design and prototyping, support until serial production
• Product example: Drug transfer systems, PEEK Cage, Liquor-Drainage System, Port-catheter system including port needle, Vertebroplasty syringe, Retractor system for minimal invasive surgery
• Risk analysis and risk assessment, quality management for medical device manufacturer according to DIN EN ISO 13485
• Clinical Evaluation including literature search and assessment of publications according to evidence based medicine