News from Arrotek

Medical Device Risk Management Plan – What You Need to Know

by Ger O'Carroll
As we have covered in a previous blog, risk management is essential when designing and developing a new medical device product. An important part of this process involves creating and maintaining a risk management plan. Before going any further, it’s helpful to define risk management. What is risk management? Risk management is not the act of carrying out a risk analysis at various points during the design of your medical device. This is an action that is part of risk management. Instead, risk management is a process and, for that process to be effective, documented, and transparent, you need a...

An Overview of Risk Management in Medical Device Product Design

by Ger O'Carroll
Risk management is an essential part of the medical device product design process. It ensures the safety of patients, users, and operators so it’s no surprise that risk management is a regulatory requirement. Risk management is also essential to the medical and commercial success of the new product you plan to develop. In terms of the processes and steps required to ensure the proper management of risk, this is part of the Quality System that you need to have in place when designing a medical device product. In addition to risk management, a Quality System includes management controls, document control,...

Arrotek has had zero turnover of permanent staff in over 12 months

by Arrotek Medical Ltd
We're delighted to announce that Arrotek has had zero turnover of permanent staff in over 12 months! This is a fantastic achievement for our company – it is a testament to you all to have a group of employees who continually strive and are committed to the continued success of Arrotek. Without you, Arrotek would not be the company it is today! Our People Make the Difference Thank you! #teamarrotek

Medical Device Design Verification and Design Validation – What They Are and Why They Are Important

by Ger O'Carroll
Design verification and design validation are essential parts of the medical device product development process. Sometimes referred to as V&V, it’s important to understand what both terms mean and how they differ if you are about to embark on a medical device product development project. This is because V&V can take more time than necessary if proper design controls are not put in place in the early stages of the design process. In other words, both design verification and design validation are made easier if you have well-documented user needs, design inputs, design outputs, and outcomes from design reviews. What...

Arrotek Sponsoring Sligo Rovers F.C. U15s team

by Arrotek Medical Ltd
We're absolutely delighted to sponsor Sligo Rovers F.C. U15s on their trip to Germany. It was great to meet the squad in person and we wish them the best of luck on the trip!  Arrotek have supported Sligo Rovers over the years to help the club with their continued success. 

Arrotek Exhibiting Med in Ireland Event Next Week

by Arrotek Medical Ltd
Arrotek will be one of the 70 indigenous Irish MedTech companies exhibiting at Med in Ireland next week. Med in Ireland is a key event for the MedTech industry both in Ireland and in Europe. Taking place once every two years, it is led by Enterprise Ireland to highlight innovation in Ireland’s MedTech sector and to showcase the technologies that are shaping future healthcare provision. More than 800 MedTech and healthcare sector executives from around the world are expected to attend the Med in Ireland event on 10 October in the RDS in Dublin. It is invitation-only, but if you...

Documenting User Needs – Key Questions You Need to Answer

by Ger O'Carroll
In a previous article, we outlined the importance of identifying and documenting user needs when designing a new medical device product. In that article, we looked at the two objectives you must achieve when documenting user needs: Defining the intended use of your new medical device product Defining the indication for use of your medical device product This sounds straightforward enough but when you go through it in practice, the process can be quite tricky, not least because documenting it is a regulatory requirement. So, how do you create the above definitions to complete the process of documenting user needs?...

How Design Changes Impact Medical Device Product Development Costs and Time to Market

by Ger O'Carroll
You have an idea for a new medical device – this is the starting point for all new product development projects. Where the project goes from there, however, the costs involved, and the timeline depends on a range of factors. Examples include the complexity of the product, availability of funding, regulatory issues, medical trials, and more. Unfortunately, you have limited control over many of these factors. That said, there is another factor that can have a substantial impact on the cost of product design as well as the time it takes to bring your new medical device to market. As...

Come Visit Our Stand at Medical Technology Ireland 2019

by Arrotek Medical Ltd
Medical Technology Ireland 2019 is taking place in Galway next week. We have a stand at the exhibition and would love to see you there. You can meet members of our team, find out more about what we do, and discuss how we can turn your idea for a medical device into a reality.   Medical Technology Ireland features over 200 exhibitors and an extensive conference programme. It takes place next Wednesday and Thursday, 25 and 26 September, at Galway Racecourse. You can register to get free entry to Medical Technology Ireland 2019 on the exhibition's website. Make sure you...