To complement the NCS offering, we offer our customers our financial expertise and expertise in international quality assurance and regulatory affairs.

Through our experience and a network of consolidated partnerships, we help our customers define the financial strategy for the project to be carried out. We can support you in the subsequent implementation phase of your financial plan up to the final report.

Europe, the United States, Canada, Latin America and even the Far East… the support of our team of experts has no boundaries in the field of Quality and Regulation. We offer strategic and operational consulting for CE marking, FDA clearance and international registrations.

R&D, Material Lab, Manufacturing & Finishing, Proto & Style, in addition to “shared sevices” are available to our customers “on demand” or for a defined period of time, through the Temporary Management service, which offers our skills, professionalism and tools, to support companies who request them.


The company certifications in place today guarantee a standardised and customised modus operandi.
For our customer’s project we build ad-hoc procedures based on a consolidated and certified methodology:

  • ISO 9001
  • ISO 13485
  • CE certification according to annex II of the European Medical Devices Directive “Complete quality assurance system”.
  • ASTER accreditation as a Laboratory belonging to the Emilia-Romagna High Technology Network
  • ACCREDIA ISO 17025 Certification (in progress)

TUV – SUD Quality System Certification
Certificate N.50 100 9205 UNI EN ISO 9001:2015

CERMET Certification CE SYSTEM of quality guarantee
Certificate N. MED 29111 Rif: law 93/42 CEE

CERMET Certification CE System of Quality Guarantee 
Certificate N. 8840-M UNI EN ISO 13485:2012

ASTER Accreditation A Emilia Romagna high technology network laboratory


  • We study with our client the most suitable financial plan to co-finance the research, development, testing or production project through access to structural funds made available by the relevant local and international authorities, or through participation in specific calls for tenders.
    We offer support from the architectural phase of the project to the drafting of the grant application, up to the reporting of what is presented.
  • Aster accreditation as a Laboratory belonging to the Emilia-Romagna High Technology Network is a requirement for access to many facilities and calls for proposals.

Working with NCS can therefore make a difference in terms of the value of the investment.

  • We support our customers in developing or creating a quality system according to the requirements of the implemented project, whether it consists of the CE marking of a Medical Device, or the management of business processes in accordance with a reference standard.
  • We can define operating procedures or manage processes, activities or tests, according to customer requirements, and validate them according to the requirements of a certified quality system.
  • We support companies operating in regulated sectors to adapt their quality system to the regulatory requirements of the sector and market of interest
  • We are studying with our Client the regulatory strategy to access the markets of interest (Europe, United States, Canada, Latin America, Meaddle and Far East).
    From the analysis of the regulatory requirements of the target market for the specific reference sector (e.g. Medical Device, In Vitro DIagnostic, Food) we conduct a feasibility analysis to support the choice of our customers regarding the best strategy for the project/company.
  • From the risk analysis, with FMEA approach, to the performance verification up to the evaluation of the technical and clinical literature, we are able to complete the drafting of the Technical File of a Medical Device or In Vitro Diagnostic, in compliance with the regulatory requirements of the target market.
  • The regulatory service is completed by support in the drafting of the documents necessary for the inclusion of products in the database of the Italian Ministry of Health (Medical Devices Repertoire) and the preparation of forms or documents for the submission of applications for approval to international regulatory bodies.
  • We can offer a 360° support service, designed ad-hoc for each of our interested customers, providing all the expertise, services and processes validated and certified by NCS, at the customer’s request or for a defined period of time.
  • By sharing a project management and control tool, we give our customers the opportunity to know in real time the progress of the activities ordered.