NCS will assist companies producing face masks against Covid-19

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.

#facemasks #visors # covid-19 # EN14683 # EN149 # EN166 #path authorization #derogation #certification

by NCS Company

Dexter™ Training model: Why training in surgery matters

Dexter™ Training model: Numbers don't lie

Training matters.

ANDRE AGASSI

Andre Agassi was committed to  hitting 1 million tennis balls each year, because his father told him, “numbers don’t lie”. A child who hits one million balls each year will be unbeatable.” During his career as a tennis athlete, he trained by running in the LA desert with his coach and spent countless hours in the gym.

FEDERICA PELLEGRINI

The Olympic champion, swims 5 hour each day, Monday through Saturday. On odd days, in addition to her swimming routine she adds a few hours of muscle toning at the gym and ends it with a session of stretching.

TANIA CAGNOTTO

The day of this Olympic champion used to begin at 9 AM when she would go to the swimming pool to train for an hour and a half with a facilitating platform and dry trampoline. She would later come back to the pool, where she would train all afternoon untill 6.30 pm. Tania also added hours of training at the gym where she lifted weights and strength exercises.

USAIN BOLT

This Jamaican athlete, said he used to train 6-7 days a week for three hours each day. His training routine includes plyometric training mix (exercises to develop muscle power), weights, all types of jumping, squats, push-ups in suspension, lunges with the dumbbell, abdominal and trunk muscle strengthening, without neglecting upper limb training.

As a runner, a good part of his training hours is focused on core stability (keeping balance on the move).

CRISTIANO RONALDO

Cristiano Ronaldo has a severe training schedule, where he works out seven days per week: Cardio activities, tread-mill, push-ups, pull-ups, abdominals, lunges and lunges with dumbbells on odd day. On even day, he has a lighter routine training.

 

These are a few examples of athlete’s training routines. They continue to hone their skills with passion and sacrifice every-day to become a champion.

Right now, even during this time when the Olympic games, championships, and races have been delayed due to the virus, athletes continue their training in their homes.  Their motivation and dedication, helps them avoid the “detraining phenomenon”, and to stay healthy and fit. Some of them, in their videos posted on social media, say that they don’t want to stop, they can’t stop.

Why for a surgeon should this be any different?  As a champion in your clinic and operating room your hard-earned skills are important to the world and to your patients.

There’s no better way to practice and condition your talents than with a Dexter™ training model. 

You have amazing skills built on experience, practice and continuous improvement. Dexter™ wants to help you keep it that way and, maybe, it allows you to develop some new ideas, your winning ace or shot, while practicing!

“Numbers don’t lie”.

Matteo Mantovani
Technical Director, CEO

by NCS Company