News from Arrotek

Arrotek’s Response to the Challenges of the Coronavirus

by Arrotek Medical Ltd
The coronavirus threat is difficult for everyone, and it’s fast-evolving. At Arrotek, we have taken steps to protect our employees as well as our customers and others. This includes following the advice provided by national and international bodies. As a result, we have begun a programme of working from home, with many members of the Arrotek team now working remotely. We are also constantly monitoring the situation and the advice being provided and will take whatever steps we can to mitigate the impact of any further access restrictions to our facilities and resources. Our priorities throughout are the health and...

COVID-19 Support message from Arrotek

by Mark Pugh
As we in Arrotek endeavour to support the measures to tackle the COVID-19 situation, one aspect that has been identified is a possible lack of cleanroom space. As I`m sure you all know, Arrotek Medical recently moved into a new facility in Sligo. The previous facility is currently empty and available. This is a facility with over 2,000 ft² of cleanroom space in a detached building of over 10,000 ft² split between warehouse and office space. Less than a year ago this facility was running as a fully validated class 7 cleanroom, and could be returned to this status quickly....

Managing Medical Device Design Project Risks

by Mark Pugh
In medical device design projects, there are both product risks and project risks. Product risks are talked about a lot as they are about the safety and effectiveness of the product. Managing product risks is also an essential part of the regulatory approval process. From a commercial perspective, project risks are critical too. Therefore, it’s also important to manage project risks when designing a new medical device. Product Risk Management vs Project Risk Management Product risk management is about product safety and ensuring the product does what it is expected to do. There are well-document guidelines, standards, and requirements you...

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:  

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...

Estimating the Probability of Occurrence and Severity of Harm When Assessing Medical Device Risks

by Ger O'Carroll
There are a number of steps that need to be taken in relation to risk management when designing a new medical device. This includes identifying hazards and hazardous situations. You then need to evaluate the hazards and hazardous situations you identify before, potentially, putting control/mitigation measures in place and then monitoring those controls. The second stage of the above process, evaluating hazards and hazardous situations, involves estimating two essential factors: The probability of occurrence The severity of harm By combining these two estimations together you will be able to define the risk as being either acceptable or unacceptable. This definition...

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