My experience in the field of Regulatory Affairs and Certification Services for the Medtech, In-vitro Diagnostics, SaMDs, BioTech and ATMPs and PPE (Personal Protective Equipment) industries and the certification of Medical Devices, DIGAs, Combination Products, Borderline Devices, Diagnostics and Legal Manufacturers lies in the training, implementation and auditing of 21 CFR 820, MDSAP, ISO 13485: 2016, GMP, GLP, GCP, ICH processes (and the transition from MDD to MDR) as well as the assessment of technical documentation (MDR / IVDR / 510k / De Novo), the implementation of risk management tools according to ISO 14971, the preparation of usability files according to ISO 62366, the biological evaluation and BERs (ISO 10993) and the clinical evaluation and CERs according to ISO 14155 and MEDDEV 2. 7.1 / Rev.4 MDR / MDCG / FDA in the technical file or for CA MDR / FDA / Anvisa / EMA, DIGAV or HMV (GKV) submissions.

I am also familiar with MDD, MDR (EU) 2017/745, Regulation (EU) 2017/746 (IVDR), REGULATION (EU) 2016/425 (Personal Protective Equipment) as well as IMDRF (GHTF), MDCG, ICH, DIGA, NB-Med and MEDDEV and FDA Guidance Documents.

I am familiar with the requirements for combination products, borderline products, procedure packs, DIGAs as defined by the BfArM and reimbursement institutions such as the GKV Spitzenverband and the requirements for biologics such as ATMPs. In this context, I am also called upon as an expert witness in legal disputes.

Through my work as Lead Auditor (Medtech / IVD), Lead Technical Assessor, Senior Certification Expert and CEO / Managing Partner in various medical device and biotech companies, I have gained a broad knowledge and expertise in the medical device, IVD, biotech and pharmaceutical industry and its regulations. I have also gained many years of consulting experience and am experienced in setting up certification strategies, standard operating procedures, and system documents.

Together with leading partners from industry (Solvay / stimOS), clinic (Charité Universitätsmedizin Berlin / Universitätsklinikum Tübingen) and certification (QS International AG), I defined and implemented the quality and transparency standard S.P.E.L. (Safety and Performance Evidence Level) for medical device and biotech components, medical surface technologies and point-of-care solutions.

My experience as an award-winning CEO (Innovation Award, State of Baden-Württemberg, 2013 / European Most Innovative Startup, MedTech 2017, Medtech Patent of the Week, DeviceMED 2021, Top 10 Orthopedic Solution Provider Europe, MedTech Outlook 12/2021), Top 10 Medical Startup Europe (MedTech Outlook O5/2022) and QM/Certification helps me to meet and define the requirements of the industry.

As an organised person with good communication skills, I have been responsible for the successful implementation of ISO 13485 / GMP; GCP and GLP in international companies. As a consultant, my responsibilities included the definition of certification strategies, the implementation of ISO 14971 risk management procedures and clinical evaluation and certification strategies. In addition to clinical evaluation, my responsibilities included the preparation (study protocol/investigator's brochure) and conduct (monitoring) of clinical trials and clinical studies, including PMCFu according to ISO 14155 for various medical devices.

As a LEAD External Auditor Medtech (Diplom SAQ), Certified Quality Auditor (European Organisation for Quality / EOQ), Clinical Investigator (consamed), Medical Writer (EMWA) and Lead Auditor and Lead Technical Assessor (NB QS International Ltd.) I am familiar with the methods and requirements of auditing, preparing, developing, and compiling quality systems and quality documentation, STED files and product documentation as well as usability files, risk management reports and clinical evaluations. These qualifications, combined with my knowledge and expertise, enable me to advise companies from an auditor's perspective and to provide tailor-made consultancy services.

As a lecturer at ETH Zurich (Regulatory and Certification, Faculty of Medicine and dTIP - digital Trial Intervention Platform), Fachhochschule Villach , 4C/MII and as a lecturer in Regulatory Affairs and Quality Assurance at the German Association of Chemists, I can present, communicate and train complex information in a clear and understandable way.

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