Freelancer profile translated to English.
Back to original languageAbout Torsten
In-vitro diagnostics is where medicine meets engineering — and where regulatory complexity can decide on the success or failure of a product.
I support IVD manufacturers, pharmaceutical companies, and clinical laboratories in successfully navigating this path: from analytical method development and performance evaluation to IVDR compliance, companion diagnostics, and clinical implementation.
What I bring:
As a physician with many years of industry experience, I work at the intersection of three areas that often operate in isolation — science, regulation, and clinical practice. This means: I don't just understand what EU IVDR or ISO 15189 require on paper, but what that specifically means for your assay, your study design, and your daily laboratory routine.
What I work with:
→ IVDR regulatory strategy and technical documentation (Class A–D)
→ Analytical and clinical performance evaluation (ISO 20916, EP series)
→ ISO 15189 / ISO 13485 — Implementation and gap assessments
→ Companion diagnostics strategy (IVDR Class C, FDA PMA/De Novo)
→ Market launch of IVD products in the EU and internationally
→ Laboratory automation and diagnostics strategy
Who I work with:
IVD manufacturers (SMEs and larger companies), biosimilar and pharmaceutical companies in CDx development, contract research organizations, and clinical laboratories on the path to accreditation.
Andromedica Consulting is based in Berlin and operates as a B2B consultancy. Collaboration ranges from targeted expert advice on individual regulatory questions to long-term project support.
Contact me when your IVD development is at a turning point — regulatory, scientific, or strategic.
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German
Native or bilingual
English
Fluent
Can work on-site
Berlin (up to 50km)
Experience
- Thermo Fisher ScientificLead Scientist CDD CMDJune 2018 - June 2023 (5 years)Hennigsdorf, BB, GermanyLead Scientist in TF Cacsadion SM Clinical Analyzer with focus on: Assay and platform development Strategic plannings Support in quality and regulatory affairs Cross-divisional and external scientific collaboration Clinical affairs
- Labor Berlin - Charité Vivantes GmbHHead of Toxicology & Pharmacology Laboratory at Labor Berlin GmbHJanuary 2011 - May 2018 (7 years and 4 months)Berlin, GermanyAccountable lead of pharmacological & toxicological lab at Labor Berlin TDM, drug screening and confirmation and general-unknown analytics 24/7 with mostly LC-MS/MS Accreditation following ISO 15189 and 17025 Reporting to Labor Berlin CEOs Participation in Charité medical students teaching Development and validation for more than 300 analyts in TDM and drug screening on LC-MS/MS Patent holder for automated LC-TOF based approach in toxicological emergency analytics Training of clinicians, paramedics, police, forensics and firefighters for toxicological and drug-related topics Different collaborations with the industry on lab automatisation, sample prep and automated LC-MS/MS
- Land BerlinHead of Poison Control Center Berlin & Toxicological Laboratory of the State of Berlin (BBGes)February 2002 - December 2010 (8 years and 10 months)
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Education
- Physician for Pharmacology and ToxicologyHannover Medical School1997Arzt für Pharmakologie und Toxikologie
- Doctor of MedicineHannover Medical School1991Doctor of Medicine - MD, Medizin