Arrotek

Arrotek Exhibiting at Virtual MedtecLIVE

by Arrotek
Update: Arrotek Technical Sales Manager Ronan Scott will be giving at talk at Virtual MedtecLIVE 2020 on the 6 Step Design Process for Medical Development. Get a ticket and find out more. This year's MedtecLIVE event is going virtual, and Arrotek will be there as an exhibitor. MedtecLIVE is an annual event that brings together all parts of the medical device industry. Last year, there were over 400 exhibitors with over 4,500 MedTech industry and medical industry professionals in attendance. With the COVID-19 emergency, however, this year's MedtecLIVE event in Germany had to be cancelled. There will still be a...

New European MDR – Key Steps to Take at a Time of Uncertainty

by Arrotek
Issues surrounding the implementation of the European Union’s new Medical Device Regulations (MDR) are a hot topic of conversation right now in the medical device industry. After all, that implementation starts in May of this year while today, significant challenges exist. Those challenges include the availability of MDR-designated Notified Bodies, the high workloads currently being experienced by those Notified Bodies, the uncertainty around grace periods, and the availability of EU-published guidance. These issues are now well-known and they are discussed and debated regularly. For example, they are scheduled to be key discussion points at the MedTech Live event taking place...

Medical Device Product Compliance – Key Questions to Ask

by Arrotek
There are key questions you need to ask about your new medical device idea as part of the process of getting approval from regulators in the markets you plan to launch in. Our animation outlines the key compliance questions you will need to answer. Watch now: https://youtu.be/uRxkxkdDONY  

An Introduction to Standard Operating Procedures

by Arrotek
When you design and develop a new medical device product, you must establish, manage, and enforce standard operating procedures, otherwise known as SOPs. What are SOPs, though, why do you need them, when do you need them, and what do you need to do? Before getting into those questions, let's look first at why SOPs are important even when you are at the early stages of developing your concept for a new medical device. Having SOPs in place and enforcing them is a requirement of regulators around the world, including in Europe and the US. More specifically, SOPs are part...

Arrotek’s Spirit of Christmas!!

by Arrotek
This year Arrotek took part in the Spirit of Christmas Gift Appeal by buying a gift for a resident of Nazareth House nursing home in Sligo. It was a small offering, but very much appreciated by the residents of Nazareth house and brightened up what can be a lonely time of year for some of the residents. Thank you to all the staff in Arrotek who took part in the appeal, and to all the staff and residents in Nazareth house for their lovely warm welcome when we went to deliver the gifts. #spiritofchristmas #timeforgiving