About us
MD squared bietet Unterstützung und Beratung für Medizinprodukte Hersteller auf dem Gebiet des Product Claim Managements über den gesamten Lebenszyklus eines Medizinproduktes von seiner Konzeption über die klinische Prüfung und Zulassung bis zur Post Market Surveillance an.
Background:
MD squared is founded in January 2017 by Dr.med. Dipl.-Ing. Claus Schaffrath, a physician and electrical engineer with 20+ years of experience in Image Guided Therapy and Medical Devices, both in Hospital and Industry.
As healthcare marketing professional Claus worked in start-up, mid-sized and large international businesses environments. He was responsible for Business Development & Product Portfolio Management over a broad spectrum of clinical areas, such as Neurology & Neurosurgery, Orthopedicsh, Spine & Trauma and Interventional Oncology & Radiology.
In an evolving regulatory environment Claus has focussed over the past years on value creation for Medical Devices via a clinically driven Product Claim Management. On this topic he has as also presented as subject matter expert on national and international conferences.
Claus’ passion is to look beyond the product and deliver integral value to customers, and - to serve this purpose - building clinical strategies, networks and strategic partnerships along the health continuum.
Certification & Support
Claus is a registered physician in the Netherlands (BIG Registration # 49911337201), certified as Manager Regulatory Affairs - Medical Devices EU & International (Certificate 1711#312500973 by TUEV-SUED), and member of the Deutsche Gesellschaft Biomedizinische Technik (DGBMT) im Verein Deutscher Elektrotechniker (VDE), of the Deutsche Gesellschaft Interventionelle Radiologie (DeGIR) in der Deutschen Roentgengesellschaft (DRG), and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
MD squared commands over a global network of healthcare practicioners, marketing, technical and regulatory experts. This enables to offer services over a broad range of clinical specialities in the Medical Device Industry and to provide consultancy with the right backing of tailored medical, regulatory and technical expertise.
From such background a robust determination of the specific technical State-of-the-Art and clinical Standard-of-Care is the foundation for creating tangible differentiation via Product Claim Management for Medical Devices over a product's life cycle.