Contact details

Dr. Konstantin von Martius
Zuccalistr. 19
80639 Munich
Germany

Email: kvmartius@t-online.de
Tel: +49 89 176782
Fax: +49 89 176773
Cell: +49 (0)172 852 3552

Dr. Konstantin von Martius

Education

1966: School Leaving Examination (Abitur), Maximilians Gymnasium, Munich, Germany
1978: Graduation to Dr. phil. (Chemistry), Leopold Franzens University, Innsbruck, Austria (summa cum laude)

Work Experience

1978: Tutor at the inorganic chemical department of University, Innsbruck, Austria
1979: Establishing the Non-active Medical Device activities of TÜV Bavaria, Munich, Germany
1982: Manager of the Non-active Medical Device Group of TÜV Bavaria
1989: Manager of the Department Chemistry, Medical Products of the Notified Body TÜV Product Service GmbH, Munich
1985-1996: Member of several DIN and CEN Technical Committees on standardization of medical disposables, risk analysis of animal tissue origin materials and biocompatibility of medical devices, Representative of German test- and certification bodies in the development phase of the MDD at several conferences and meetings organized by EU Commission, RAPS, etc.
1996-2009: Principal Consultant with responsibility for the German speaking Countries at Quintiles Consulting, Munich
2010: Foundation of MTC Medical Technology Consultants GmbH, CEO

Work Skills

Testing and regulatory affairs of active and non-active medical devices and active implantable medical devices, drug/device borderline and combination products, chemical-, physical-, microbiological (sterilization) and biological safety, plastic and metallic materials Quality Management Systems, development, implementation and auditing of quality systems of manufacturers of active-, active implantable- and non-active medical devices, regulatory and technical due diligence audits

Responsibility for more than 200 CE Conformity assessments for the major medical device manufactures (active, active implantable, non-active and non-active implantable MDs)
More than 100 registered third party audits most as part of CE Conformity Assessments for the major medical device manufacturers − Alcon, Baxter, Braun Melsungen, Fresenius, J&J, Medtronic, Med-EL, Phonac, etc. − and for some medicinal product manufacturers (borderline products) − Bayer, B&L, Almirall, etc.
ca. 25 internal audits based on ISO 9000 / ISO 13485 / FDA GMP / EEC MDD requirements in a team with US FDA GMP specialized auditors
ca. 35 supplier/subcontractor and due diligence audits
Manufacturing processes, qualification and validation
Support of manufacturers in MD vigilance cases
Preparation, compilation and update of Technical Documentations, Design Dossiers and Consultation Files, in particular for drug / device borderline and combination products and ophthalmic products, Risk Management report, ER-Checklist, Biological Safety Report
CE Conformity Assessments, in particular for drug / device borderline and combination products

Additional Training

BSI Lead Auditor Course and Certfication
Certified QMS 2000 Lead Auditor according to IRCA (UK) and TGA (D)
SQA Senior Quality Auditor

Publications

On regulatory, chemical and technical matters and QA-system questions related to medical devices in the following journals: Medizinprodukte Journal, FÄPI Mitteilungen, Megra Mitteilungen, Medizintechnik, Pharma News, extracta orthopaedica, Sportmedizin, Jatros Ortho,Medizin aktuell, Clinica, ABHI focus, World Markets Research Centre

Presentations

Since 1988 on several conferences and seminars organized by EC-Commission, EUCOMED, RAPS, Medical Device Technology, DIA, Medinform, Concept Heidelberg, MEGRA, MEDTEC, fmbt, Aventis, Baxter, Merckle-Ratiopharm, Medtronic, Gammaster, Roche Consumer Health, CAESAR Center of Advanced European Studies and Research, Lector at University Augsburg Faculty of Law on annual Medical Device Legislation Training Courses

References on Recent Activities

Regulatory affairs on various medical devices, Classification, Demarcation, Drug/Device Borderline Products
Consultation dossiers and discussion with European Medicines Agency (EMA)
Compilation and review of MDD and IVDMDD Essential Requirements Checklists, Risk Analysis Documents and Technical Documentation for various products, e. g. cardiovascular products, infusion pumps, bone substitutes, ophthalmic borderline and implantable products, diagnostic biochips, by-pass surgery accessories, dermal products, patch tests, etc.
CE Marking of Medical Devices for the Pharma and Cosmetic Industry
Vigilance issue concerning an orthopedic implant in Germany (BfArM) and UK (MHRA)
Certification audits of various manufacturers of Hg Thermometers, Sphygnomnometers, sterile disposables, active diagnostic medical devices in China (subcontracted by Notified Bodies). Audit of IOL manufacturer in Japan
Due diligence audits of European manufacturers of active implantable medical devices, drug/device borderline products, and x-ray equipment in context with mergers & acquisitions
Supplier audits for major US healthcare companies of European manufacturers of HLM blood-line-systems, dental products, active implants, infusion solutions, in-vitro diagnostic disposable devices and nasal drug delivery systems in context with enlargement of product portfolio and electronic components manufacturers
Subcontractor audits of European logistics and distribution companies for a Japanese drug and medical device manufacturer
Preparation of documents, EC submission, notification, initiation and management of a multi-center study in the surgical area
Regulatory advice for a leading international manufacturer in the disinfectants and cleaning agents industry. Borderline Biocides / Medical Devices / Medicinal Substances / Cosmetics / Multi Purpose Products

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