Medical Device Engineering was created in July 2012 from two complementary backgrounds.

Cyrille Maréchal

Plastic engineer, begining his carrier in several R&D centers (automotive, cycle industry etc.), he joined many manufacturing companies as R&D director and board member in pharmaceutical and medical field.

Former CEO and founder of Top Clean Injection, with 17 years R&D experience, Cyrille Maréchal decided to create a new company dedicated to development of innovative medical devices. He is bringing his experience of medical device design, injection molding in clean room, OEM manufacturing...

Nadège Morand

PhD Neurosciences, Associate Professor in University of Franche Comté (France) since 2001, she is actually laid off to dedicate itself to Medical Device Engineering activities. 

Associate Professor in Human and Animal Physiology, researcher in cellular neurobiology and pharmacology, author of several scientific articles in international peer reviewed journals, with 15 years research experience, she is bringing her knowledge in medicine, animal experiments, fondamental and clinical research. 

Main Skills & Features...

  • High experience of the medical industry, including its specificities & related problematics (GMP, ISO 13-485, production in cleanrooms...)

  • Multi-fields experience in Medical Devices design & development                                       (Class I, II, III)

  • Specialized in Injection Moulding tool development, & related process & equipments     (Europe, Asia... )

  • Scientifical approach of our Customers’ issues & Projects                                       (Validation Plan, Clinical test management, in vivo, in vitro...)

  • Support on Process Qualification plans & protocoles                                                         (DQ, IQ, OQ, PQ type)

  • Experienced with EU & US regulation systems                                                                     (CE labeling, FDA 510K ...)

  • Accreditations, & Tax credits (CIR), Support in your CIR file building & submissions ... 

Be sure that your project(s) will be supported by the right skills, at the right time to succeed:

  • Technical issues & risks reduction :

...Given by bringing early enough the right competences , & spending the right amount of time on the projects.

  • Customers need an expertise for suitable technical solutions and supplier proposals.
  • Taking care of all the regulatory affairs on the Health Field :

...from the very beginning of the project, to integrate them from the technical choices point of view.

  • Reducing the lead time of the projects by a better & more efficient support.
  • Sharing our experience & expertize on Medical Device Field.