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DM2TC provides advice, know-how and hands-on work to help industries and startups, active in the field of medical devices (also including or even being software), through the steps of product realization, from the idea to the marketable product:

From
                                idea to prototype

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From prototype to product

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From product to marketable product

  • Conceptualization and feasibility study
  • R&D project design & management according to ISO 13485 and 21 CFR 820 requirements (including documentation of design inputs, outputs, verification, & validation)
  • Support for building up technical file or design dossiers, including risk management, usability engineering, ...

  • Technology transfer
  • Manufacturing set up, implementation and control (including qualification and control of subcontractors & suppliers, metrology, environmental controls, maintenance, in-process and release tests, batch records, ...
  • Special processes validation (packaging, sterilization, ...)

  • Quality management system (ISO 13485, 21 CFR 820) implementation and support through certification
  • Regulatory files (CE marking, 510(k), PMA, ...) and help through certification/approval process
  • Market access regulatory submissions
  • Post-production (post-market) surveillance
  • Internal audits, trainings, ...



Alberto Della Martina has obtained an engineering master’s degree in materials science and a Ph.D. in polymers science from the Swiss Federal Institute of Technology in Lausanne.
He has accumulated more than 14 years of experience in R&D, engineering, industrial development and quality systems in medical devices, pharma, and cosmetics startups and industries.
To date, he is the author or co-author of 16 publications in peer-reviewed scientific journals, of 3 patents, and he regularly performs peer reviews for a polymer science journal.
He started his consulting activity in February, 2009 and has since reached numerous achievements for his clients.



DM2TC Sārl
Av. Hugonnet 15
CH - 1110 MORGES



Mobile: +41 (0)76 497 35 35
Email: info@dm2tc.ch



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