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New Product Development

Our engineering and development services provide manufacturers with a bespoke service, which is related to the development and prototyping of electro-medical devices and disposables. Many companies have limited resources and may lack the internal expertise to invest in new and complex products as these require dedicated and extensive engineering management.

S4MDC offers the following services:

Design and develop electro-medical devices or subsets following client specifications. The deliverables are:

1) Product feasibility analysis with subsequent project costs, timing and cost of production

2) Project Management to develop the product. This includes:

  • Mechanical design including optional printed prototypes
  • Customized electronic boards vs commercially available solutions
  • Software development for stand alone or integrated solutions

All projects are in accordance with the IEC 62304 (related to the software life cycle process of medical devices)

3) Support for product certification (CE and FDA) and production:

  • Risk management process according to the definition and classification of the product and all the subsequent activities of risk analysis to achieve FMECA
  • Generation of instruction manuals and technical documentation necessary for certification.
  • Management of the laboratory testing required for certification
  • Certification filings to relevant authorities
  • Industrialization of the product or alternatively management outsourced production process
  • Management and development of production processes including the validation of manufacturing processes
  • Implementation of QA standards for production process