NCS America changes its name as part of an overall rebranding initiative. NCS America is now Alyve Medical, Inc.

NCS  | PRESS RELEASE

NCS America changes its name as part of an overall rebranding initiative.

“As founder of NCS America, I am proud to share this important evolution: the creation of Alyve Medical. This name change reflects our positioning and the growth potential for our technologies. Together, we intend to disrupt and enhance the standard of musculoskeletal care” Matteo Mantovani, CEO of NCS Lab s.r.l. and co-founder of NCS America in response to the new name.

NCS America, Inc. was the initial U.S. organization created for the business operations and commercialization of the two products developed at NCS Lab srl in Carpi, Italy. Alyve Medical will continue to be the business entity for global operations and commercialization.

 

Alyve Medical, Inc. emphasizes the “y”, for you, focused on the individualized treatment that its products provide. It also serves as an ally to the patient or athlete to support them in their musculoskeletal health and optimization.

Alyve Medical Inc. is a novel medical technology company focused on reimagining the management of musculoskeletal care.

The two innovative and novel platforms (Shoulder Pacemaker™ and ShowMotion™) developed by NCS Lab Srl (Carpi, Italy) and released for sale to the EU, USA and many International Markets, will be the main focus of the new entity to aid worldwide clinicians in diagnosing, treating and preventing musculoskeletal injuries.

These non-invasive technologies, deployed in physician offices and physical therapy clinics today are being used to observe normal and abnormal joint function in orthopedic treatments, physical therapy delivery, and athletic performance.

Multiple studies are in progress validating and confirming this transformation in the way human movements are evaluated, measured and rehabilitated.

Alyve Medical, Inc. appoints new CEO: Yvonne Bokelman

After being NCS Company Chief Operating Officier through the past four months, Yvonne Bokelman has been appointed new CEO of Alyve Medical.

“I am honored by this opportunity,” said Ms. Bokelman. “The talent and passion of the team combined with the innovative products that they have developed create a unique go-to-market environment in which to excel. To lead a company that has novel, first-in-class products that can change the paradigm of care and positively impact patients’ lives and athletes’ training and recovery is incredibly energizing. This period in the company’s evolution presents an unparalleled opportunity for our current and future stakeholders as well as the team.”

Prior to joining NCS and Alyve Medical, Ms. Bokelman held the position of President and General Manager of Restorative Therapies, Market Access and Clinical Affairs at Zimmer Biomet. In her over ten years at Zimmer Biomet, she held a number of increasingly responsible leadership and executive roles.

 

With the overall company rebranding, the Shoulder Pacemaker™ name will change and both Shoulder Pacemaker™ and Showmotion™ will be transitioning to new graphics and logos.

 

To align with the company’s direction and to meet market demands, Shoulder Pacemaker™ and Showmotion™ will be transitioning their “look” in the coming weeks and months.
Join us in celebrating a new name for Shoulder Pacemaker™ as it becomes Neuralign System™ S.
A new brand, with the same product quality and customer care known to date, but with a new look to the future.

All customers who are now in possession of Shoulder Pacemaker™ and Showmotion™ will continue to be followed by our growing team, with the same care and attention to detail that distinguished NCS.
Our customer care department is available to support you for technical and commercial needs.
To learn more about Alyve Medical we invite you to visit the website www.alyvemedical.com and follow our social channels to stay updated on new developments.

 

Alyve Medical
www.alyvemedical.com


Carpi 3000 sceglie Shoulder Pacemaker™ e Showmotion™: il primo starter KIT in Italia, per una riabilitazione all'avanguardia.

NCS  | Press Release

Carpi 3000 sceglie Shoulder Pacemaker™ e Showmotion: il primo starter KIT in Italia, per una riabilitazione all’avanguardia.

Carpi 3000, poliambulatorio specialistico di riferimento per la città di Carpi, ha deciso di implementare i propri servizi scegliendo la tecnologia di Shoulder Pacemaker™ e Showmotion™ di NCS Company.

Carpi 3000: il poliambulatorio specialistico di riferimento per la città di Carpi

Carpi 3000 è un poliambulatorio specialistico, punto di riferimento in città, che si rivolge a pazienti con disturbi di tipo ortopedico, neurologico, degenerativo e traumatico.

A Carpi 3000 ogni paziente è seguito da medici specializzati e da fisioterapisti qualificati per garantire la migliore cura e attenzione: dall’identificazione di una diagnosi, al recupero attraverso programmi clinici e riabilitativi specifici e con strumenti all’avanguardia.

La tecnologia di Showmotion™ e Shoulder Pacemaker™ per il benessere della spalla

Showmotion™ e Shoulder Pacemaker™ sono due device di NCS che, abbinando uno strumento di motion capture ad un dispositivo che introduce un nuovo concetto di stimolazione  guidata dal movimento, contribuiscono al ripristino della corretta funzionalità di spalla.

Dott.ssa Tizia Ghelfi – Fisioterapista e Titolare del centro Carpi 3000

“Con Showmotion non solo abbiamo la possibilità di formulare diagnosi più accurate, ma soprattutto di monitorare il percorso del paziente in modo analitico, passo dopo passo.
Shoulder Pacemaker
™ per noi è una vera innovazione nel panorama della riabilitazione di spalla, non poteva non essere presente in un centro come il nostro” afferma Tiziana Ghelfi, titolare del centro.

 

 

 

 

 

 

 

Il primo starter kit in Italia

Carpi 3000 è il primo centro in Italia che ha scelto di avvalersi della formula Starter Kit
“Avere a disposizione uno starter kit di questo tipo significa poter garantire al paziente le cure migliori, direttamente presso il centro, ma anche a casa grazie ai dispositivi specificatamente customizzati ad uso domestico, sempre supervisionati dal fisioterapista.” continua sempre Tiziana Ghelfi.


Lo starter kit comprende:

  • 1 Showmotion™ Total Body con 12 sensori
  • 2 KIT SHOULDER PACEMAKER™ wireless app
  • 10 KIT SHOULDER PACEMAKER™ WIRELESS APP HOME

Lo starter kit rappresenta quindi un bundle completo per coloro che decidono di inserire la tecnologia di #SM e #SPM all’interno del proprio centro, offrendo al paziente un percorso completo che supporta la diagnosi, valuta e monitora gli avanzamenti e permette la continuità di riabilitazione anche a casa.

(Per informazioni in merito alla configurazione dello STARTER KIT vi invitiamo a contattare il product specialist di riferimento, Matteo Barbolini: productspecialist1@ncs-company.com)

Contatti

Matteo Barbolini
Product Specialist
+39 3457183686

productspecialist1@ncs-company.com

Vuoi saperne di più? Scrivici!

_ _ _ _

Comunicato stampa ufficiale Comune di Peccioli: QUI


Showmotion™ & Shoulder Pacemaker™ protagonisti nel primo progetto di screening muscolo-scheletrico in Italia.

NCS  | Press Release

Showmotion™ & Shoulder Pacemaker™ protagonisti nel primo progetto di screening muscolo-scheletrico in Italia.

Si è tenuta qualche giorno fa a Peccioli (PI) l’assemblea pubblica di presentazione del progetto “Peccioli over 50 in salute”: il primo progetto di screening in Italia per patologie muscoloscheletriche rivolto a tutti i cittadini over 50 prese.

Il progetto Peccioli over 50 in salute

Il progetto, presentato dal Dr. Michele Novi (Dirigente medico della struttura organizzativa complessa di  ortopedica protesica dell’ospedale di S. Pietro Igneo di Fucecchio), allievo del Prof. Michele Lisanti e del Prof. Giuseppe Porcellini,  lo vedrà impegnato, insieme alla sua squadra, in un progetto di prevenzione finalizzato all’inclusività e intensità di cure anche verso i soggetti più fragili.

Un intervento molto importante perché ogni anno il numero di persone interessate da patologie muscolo-scheletriche legate alle articolazioni di spalla – ginocchio ed anca è in aumento, considerando inoltre che la pandemia ha evidenziato ulteriormente i limiti e le difficoltà del sistema tradizionale di riabilitazione a causa delle limitate possibilità di movimento e per i provider a causa delle nuove regole imposte dall’emergenza sanitaria.

Showmotion™ & Shoulder Pacemaker™ a servizio della prevenzione

Showmotion™ & Shoulder Pacemaker™ si inseriscono in questo progetto in maniera circolare attraverso le 3 fasi di: prevenzione, riabilitazione, monitoraggio.
L’assemblea pubblica è stata l’occasione per NCS di illustrare le principali funzionalità e caratteristiche dei dispositivi che saranno utilizzati in questo ambizioso progetto.

Showmotion

Nella fase di screen sarà quindi utilizzato Showmotion come strumento di supporto alla diagnosi, utile per acquisire i dati cinematici.

Sowmotion™ è uno strumento innovativo che permette di eseguire un’analisi completa del movimento ottenendo contemporaneamente dati sull’attivazione muscolare.

Attraverso l’utilizzo di una piattaforma inerziale e di protocolli validati per gli arti superiori e inferiori, Showmotion™ permette di misurare, registrare, segmentare, confrontare, visualizzare i movimenti e fornire una rappresentazione visiva delle variabili coinvolte, portando alla luce eventuali disfunzionalità grazie ad un’analisi real-time del movimento.

>>> Per maggiorni informazioni sulla tecnologia fai clic QUI

Shoulder Pacemaker

Altro protagonista del progetto di screening “Peccioli in Salute” è Shoulder Pacemaker™

Shoulder Pacemaker™ è un sistema che grazie al sensore cinematico presente al suo interno, riconosce il movimento e attiva l’elettrostimolazione solo quando necessario.È concepito per pazienti affetti da uno squilibrio nel reclutamento muscolare ed è dotato di una piattaforma che consente ai pazienti di interagire dinamicamente con il dispositivo durante la riabilitazione attiva.

>>> Per maggiori informazioni sulla tecnologia fai clic QUI

Un progetto pilota per il rinnovo della telemedicina in Italia

Il progetto Peccioli over 50 in “salute” si traduce nel tentativo di instaurare un sistema di trattamento virtuoso che permette di avvicinare i providers ai pazienti, monitorare l’intero processo fino al risultato finale e certificare l’esito ultimo.

Un progetto pilota che pone le basi per innovare il recente campo della telemedicina e divenire un unicum in Italia, in cui la popolazione eterogenea di un paese intero può accedere a tecnologie oggi ad appannaggio solo di sportivi professionisti o grandi centri universitari con finalità di studio.

È un onore per NCS vedere come, le tecnologie innovative di Shoulder Pacemaker™ e Showmotion™, possano contribuire in modo reale al miglioramento della salute dei pazienti, e della popolazione

Contatti

Matteo Barbolini
Product Specialist
+39 3457183686

productspecialist1@ncs-company.com

Vuoi saperne di più? Scrivici!

_ _ _ _

Comunicato stampa ufficiale Comune di Peccioli: QUI


NCS America, Inc. launches the Shoulder Pacemaker™ after receiving FDA clearance

NCS America, Inc. | Press Release

NCS America, Inc. launches the Shoulder Pacemaker™ after receiving FDA clearance

NCS America, Inc. a world leader in developing technology to help diagnose, treat and prevent musculoskeletal injuries, today announced the expansion of their breakthrough product offerings with the FDA clearance of the Shoulder Pacemaker™ and its patented motion activated stimulation (MAS) technology.

 

 

Shoulder Pacemaker Device

What is the Shoulder Pacemaker™ device?

The Shoulder Pacemaker™ is an NMES device designed for use in muscle re-education, maintaining or increasing range of motion, and in the prevention or retardation of disuse atrophy.

Matteo Mantovani Technical Director – CEO, NCS Lab

Motion activated stimulation is taking NMES to a new level said Matteo Mantovani, CEO and technical director of NCS Lab srl.

“This product advances NMES therapy with the ability to deliver stimulation with precision and accuracy in order to help re-educate imbalance muscular activity in the shoulder. Stimulation controlled by movement means restoring the right muscles recruitment pattern.
In addition to this, automatic remote monitoring and reporting, checking both for the patient’s compliance and evolution, represent a significant benefit for patients and healthcare providers.

 

  John Winslow CEO – NCS America, Inc.

John Winslow CEO – NCS America, Inc.John Winslow, CEO of NCS America, Inc. says “We are very pleased to receive the FDA clearance of the of the Shoulder Pacemaker™ which provides an exciting extension to the NCS product portfolio for the United States market. Our experience in Europe has proven that the market’s interest in motion activated muscle stimulation (MAS) is far beyond our original expectations. We are happy to make the device available in the U.S. to caregivers whose patients will benefit from this technology.”


NCS America, Inc.

NCS America, Inc. is the U.S. headquarter of NCS, a global medical device company focused on upper extremity and orthopedic pathologies.
With our deep understanding and experience in the biomechanics of the shoulder we design, manufacture and market technology that assists caregivers in the diagnosis, treatment and prevention of orthopedic injuries.
With operational headquarters in Carpi, Italy and in the U.S. in Denver, Colorado, NCS’s products are sold in over 20 countries via the Company’s sales representatives and distributors.

www.shoulderpacemaker.comDownload Press Release (PDF)

NCS AMERICA, INC. Contact References

John Winslow
CEO – NCS America, Inc.
j.winslow@ncs-company.com
970-980-1110

Craig Kramer
VP of Business Development – NCS America, Inc.
c.kramer@ncs-company.com
317-441-4289

Forward-Looking Statements

This communication contains forward-looking statements.
Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.


Rotator Cuff - Cuffia dei rotatori

Why is transosseous arthroscopy considered the gold standard in rotator cuff repair?

Why is transosseous arthroscopy considered the gold standard in rotator cuff repair?

The transosseous approach is generally recognized as the gold standard for surgical repair of the rotator cuff.

We can list here the main reasons:

  • Widely recognized by the scientific community
  • Numerous supporting publications
  • No hardware in the footprint
  • Possibility to decorticate
  • Larger tendon-bone contact area
  • Uniform force distribution - no load peaks
  • Biologically better repair

Transosseous Arthroscopy: advantages

What are the advantages for the patient? And for the physician?

With the transosseous approach, you have the ability to manage any type of rotator cuff injury.
Combined with a proper rehabilitation protocol, patients have a faster functional recovery and the rehabilitation phase has less pain than other comparable procedures.

On the other hand, for the physician, transosseous repair means:

  • Biologically better repair
  • Optimal management of revision cases, cysts and osteoporotic bone (with augmentation)
  • Cost-effective

Transosseous Arthroscopy: critical issues

But What are the main errors and critical issues that can be encountered?

As with other techniques, critical issues or steps that require a major learning curve may be encountered in TO.

We have identified the following:

  • How to load sutures in a Transosseous Tunnel
  • How to create multiple tunnels?
  • Converging tunnels, how to do it?
  • How to access the lateral part of the greater tuberosity: what are the difficulties when going distal, and can the axillary nerve be a problem?
  • Is tying the knot in a transosseous technique equivalent to the anchor approach?
  • What are the pitfalls with osteoporotic bones? Is there a way to overcome the problem?
  • Augmentation, as a remedy for suture slippage?
  • Identification of portals

Webinar: “Transosseous opportunity, a practical overview”

Together with Prof. Alessandro Castagna, Dr. Pol Hujisman and Dr. Claudio Chillemi we will talk about transosseous surgery in the rotator cuff on April 28th at 7 pm.

Based on their experience, we will give a complete overview of the different transosseous procedures with the aim of explaining the different techniques and their advantages by comparing our understanding with the professionals of the sector.

The meeting will be an opportunity to give a clear and comprehensive idea of the possibilities and advantages that this approach can bring, to both the medical and patient perspective.

Together with the professionals, the protagonists will be the Taylor Stitcher, the GT-Tunneler and the Dexter Training Model: all NCS's surgical devices dedicated to transosseous.

Free webinar “Transosseous opportunity, a practical overview"
April 28 2021 | 7.00 -7.45 pm CET / 1.00– 1.45 pm EST
Registrati ora: https://ncs-company.com/en/

  • 19.00 Istitutional Welcome + Introduction (Ing. M. Mantovani)
  • 19.05 Re-live Taylor Stitcher (Prof. A .Castagna)
  • 19.10 Re-live GT-Tunneler (Dr. P. Huysmans)
  • 19.15 Re-live augmentation (Dr. C. Chillemi)
  • 19.20 Transosseous, the derby: how do I select my technique (A.Castagna vs P. Huysmans, moderator: Dr. C. Chillemi)
  • 19.40 Common mistakes in Transosseous on Dexter model
  • 19.50 Q&A

 

 


Calendario Webinar NCS 2021

NCS WEBINAR 2021: learning moments, together

NCS - Events

NCS WEBINAR 2021: learning moments, together

Together, even if physically distant.
Looking forward to welcoming you back to NCS in person, we wanted to repeat the success of the 2020 webinars with a new calendar for 2021.
This is our way of keeping in touch, and letting you know how we can support you in your activities.

45 minutes: a “light & easy” format with industry experts.

The occasion will be to talk about new technologies, present the latest NCS news and discuss things together in a format that we like to call light & easy: 45 minutes together, where we will give space for reports, but above all for interaction with you.
Our webinars are free of charge, and together with the NCS experts, we will give the floor from time to time to experts, so that we can deepen each thematic topic from different points of view.

The speakers will be:
– Experts in the field
– Doctors
– End customers
We will examine concrete cases and be ready to respond to all your needs.
In order to reach a larger audience, our webinars will be held in English, and at pre-evening hours (Rome time zone).

NCS Events Calendar: dates & topics

The events calendar is in the works, and you will find all the updated dates on our website in the Events section, but we can already give you a small preview of the first events:

– 28 April 2021: “Transosseous opportunity, a practical overview”.
– May 2021: “Showmotion: diagnostic vs rehabilitation, which scope makes the most of Showmotion technology?”
– June 2021: Mutifix Hand & Wrist
– June 2021: Failure Analysis
– July 2021: New Shoulder Pacemaker Protocols
– September 2021: Dexter Training Model – Surgical Simulator
– October 2021: Transosseous Academy
– November 2021: Shoulderpacemaker & sports applications
– December 2021: Showmotion Technology

How to participate

To register for the free NCS webinars, simply register for the desired event on the “Events” page by filling out the registration form.
Once you have registered, you will receive a confirmation email containing a link to access the webinar at the defined date and time.
ZOOM, the platform we will use, will give you the possibility to follow the events in front of your PC or wherever you prefer from your smartphone/tablet.

We look forward to seeing you online!



PoliMi and NCS Company together again

NCS & Polimi, insieme

PoliMi e NCS Company together for a new green project: Electric

As in the past five years, NCS Company has been calling to support PoliMi Motorcycle Factory.

Who is PoliMi

PoliMi Motorcycle Factory (PMF) is a legitimate racing team, which began in the Mechanical Department of the Politecnico di Milano. It currently participates in Motostudent, an international competition against universities from all over the world.

Why MotoStudent

The purpose of MotoStudent is to allow students apply the knowledge that they have acquired during their studies and verify it in a competitive situation. The tasks and problems that the team members have to overcome are the same problems that are faced by every professional team racing in international competitions.

For this reason, they have to project, develop, build and assembly all the components and the electronic. Moreover the team also needs good organisation and logistics during events and presentations of the prototype, effective collaborations and relationships with sponsors and suppliers as well as promoting the team image and the prototype on social media.

The collaboration with NCS

Since the first edition in which PoliMi has participated with NCS , MotoStudent IV 2015-2016, the results have been immediately encouraging. With the project ‘’Scighera’’, thanks to the extraordinary commitment of the team and the help of NCS for molds and fairings, the PoliMi Team been able to realize a motorcycle prototype with above-average-performance, and the score that they reach had never been achieve before in a MotoStudent competition.

To a more green race

This new season raises the bar, the goal is to create a new prototype called "Electric" which will be competing in electric category of MotoStudent.

For this project, the NCS Team of experts in rapyd prototype has realized the molds adapted to a 100% electric motorcycle. expecting an aerodynamic fairing which can provide exellente performance; paving with PoliMi the way towards the motorcycle races of the future.

>>>SCIGHERA wins MOTOSTUDENT 2018, the world championship>>>

NCS and VIMERCATI: a world premiere collaboration

NCS & VIMERCATI, Together.

NCS and VIMERCATI: a world premiere collaboration

In a world that is trying to resume its green, during an ever faster race against time, the Automotive sector could not be less ambitious in its goal of designing and manufacturing not only everyday cars but also sustainable hypercars: the new cars of a future now present, high performance electric cars with advanced and avant-garde design.

It is precisely in this perspective that we are proud to sign new and important collaborations with VIMERCATI SPA that sees us working together to guarantee the new frontier of automotive that will be presented as world premiere in the first and unique Made in Italy luxury HyperCar on July 2020.

This will be the first HyperCar to have the exclusive worldwide product of this Great Collaboration.

VIMERCATI is a historical italian company in the field of automotive market widely known worldwide, focused on mechatronics, that join the multi-sector expertise of NCS Company, a Carpi-based company founded in the racing & automotive sector and specialized in the production of aesthetic and functional prototypes thanks to one of the largest additive manufacturing fleets in Europe.

NCS Company and VIMERCATI SPA will create together the revolutionary product for all the most important World Car Makers.

Thanks to this partnership, that fills us with pride, we attended together with a group of selected key-suppliers an exclusive international presentation event in the presence of legendary drivers of the highest formula.

This is a great award for us at NCS Company, a recognition for all the hours of work, commitment and passion of the entire team for the production of high technology products and very high added value, where handmade in Italy is real and where technology becomes the greatest expression of contemporary art.

A special thanks goes to all Vimercati SPA team starting from GM Mauro Pizi, Riccardo Marra, Marco Boano and the whole development team.

#TeamNCS
#VimercatiSPA
#HyperCar
#Jewelry
#WOWeffect
#WeAreInnovation
#FattoamanoinItalia

Download pdf press release

VIMERCATI Spa | Committed to excellence >>> https://www.vimercati.com/


NCS Lab receives funding for development of TOTEM

NCS Lab receives funding from the Ministry of Economic Development from its Horizon 2020 - PON 2014/2020 funds for development of TOTEM (TOTal Ergonomic Measurement Platform). 

The project involves the development of a device  for real-time, validated tracking  of worker's  ergonomic behavior during their daily activities.

 

TOTEM allows the user to:

  • Track, quantify and analyze user movements
  • Automatically recognize specific tasks
  • Suggest corrections to prevent wrong and potentially harmful movements

The goal is to protect the health of an employee, increase productivity and reduce inefficiencies; This high-tech device will monitor and detect the causes of the most common occupational injuries and to identify and prevent the reporting of false injuries.

TOTEM will use virtual-reality and inertial sensors to display workers movements on a screen in order to provide immediate feedback to the worker. This will allow multiple workers to be evaluated and monitored without the need for a dedicated observer. This has major implications for improving and monitoring employee health, efficiency and financial savings to the company.

Thanks to TOTEM the worker will be able to correct potentially harmful behavior during exercise and work by learning to perform every movement in the best way to avoid  compensation movements often harmful to the person's health.
TOTEM will analyze and record the results of a worker's single session and will create a report comparing and identifying any changes from previous sessions.

The High-tech nature of TOTEM will further assist in creating a “smart factory” to help ensure a safe working environment and improve work quality.

The project is a collaboration among NCS Lab and Istituto Clinico Polispecialistico (COT) for the development phase and the Campus Biomedico di Roma for scientific validation, accuracy and real-world usability. The results of this collaboration will be to commercialize a functional product, optimized and integrated with apps and  ease of use.

 


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