26 mei 2021
As of today, Nemo Healthcare has become officially MDR Certified!
Veldhoven, The Netherlands – May 26nd 2021
From May 26th, 2021 the European Union’s (EU) Medical Device Directive (MDD) will no longer be valid. From this date the EU Medical Device Regulation (MDR) will be the new regulatory framework applicable for all Medical Devices placed in the market in the EU.
Under supervision of the Notified Body DARE!! of Woerden, The Netherlands, Nemo Healthcare worked hard to obtain this new certificate which is needed to continue the successful and safe rollout of the Nemo Fetal Monitoring Solution.
“Operating to the latest standards is in the DNA of Nemo Healthcare. Our clients and their patients therefor benefit from safe and interference free (EMC) medical equipment and devices. Working with DARE!! to obtain this goal has been exemplary for the professional working relationship we have had with DARE!! for the past years.”, says Michiel Manuel, CEO of Nemo Healthcare.
In 2017 the European Union declared that it was time for a revision of directives:
'a fundamental revision of the directives is needed to establish a robust, transparent, predicable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.'
European Commission - 5 April 2017
Nemo Healthcare started in 2017 to explore the consequences and benefits of the new MDR which ultimately resulted in Nemo Healthcare becoming one of the first Medical Device companies in the Netherlands to be certified.
“With our new NFMS (Nemo Fetal Monitoring System) we add to the safety and comfort of births in Europe and beyond. Being at the finish-line so far ahead of the deadline, helps us to focus on our mission; safe births, healthy children“, says Will Ickenroth, VP Business Development, Marketing & Sales.
For more information please contact:
Will Ickenroth, email@example.com