NCS: Certification, Services.

As a result of the Covid-19 virus spread around the world there is a significant demand for face masks and other PPE products.
In a recent speech, the Italian government’s Civil Protection Chief Angelo Borrelli declared that the demand for facemasks alone is around 90 million units per month.
To meet this unprecedented demand, many companies and factories throughout Italy are converting their production capacity to assist in meeting this demand and to help our medical front-line workers.

The “Cure Italy” decree approved by the Italian government provides two solutions to help in solving this demand:  One; they have allocated 50 million euros to be distributed to participating companies in the form of non-refundable loans to produce masks.  Two; they are reducing some of the regulatory restrictions by relaxing the current regulations in order to speed up the process.

This however does not exempt companies from following all other regulations for medical device manufacturing and quality.  Face masks are still considered Medical Devices (MD) or Personal Protection Devices (PPE).  This leaves the question, how will masks be evaluated and considered safe for the users? What is the right process and procedure to follow prior to offering these products to the market?

With our well-established understanding of developing and manufacturing medical devices, we stand ready to help meet this challenge.

NCS has developed a service that will assist producers who are planning to produce PPE and who may not have all the experience or knowhow required.  Our team will assist in all aspects of understanding and meeting the government’s rules and regulations around producing medical grade products.

With our vast experience, we are able to provide the following services:

  • Support in the first stages of device evaluation
  • Offer real-time support in the development process
  • Implement performance evaluation in compliance with reference standards
  • Assist in drafting all necessary documents to obtain authorization
  • Provide proof of efficacy in our Lab where we test and certify to meet filtering characteristics

These are all activities necessary in preparation for CE conformity marking that is mandatory in order to sell after the end of this emergency period.

Because masks and all PPE equipment are fundamental aids to reduce the risk and spread of the infection, it is necessary to proceed on a clear and defined path.  We are committed to helping you manufacture and market non-harmful and useful PPE and helping you do it correctly.

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