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 … An Overview of Risk Management in Medical Device Product Design
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 … Arrotek has had zero turnover of permanent staff in over 12 months
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 … Medical Device Design Verification and Design Validation – What They Are and Why They Are Important
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 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 … Arrotek Exhibiting Med in Ireland Event Next Week
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: This sounds straightforward enough but when you go through it in practice, the process can be quite tricky, … Documenting User Needs – Key Questions You Need to Answer
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 … How Design Changes Impact Medical Device Product Development Costs and Time to Market
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 … Come Visit Our Stand at Medical Technology Ireland 2019
When you first came up with your idea for a new medical device, you probably had a fairly clear picture of how it could help improve health outcomes. In the medical device product design process, this is known as User Needs. What often happens next, however, is new ideas start to come to mind. For … What You Need to Know About User Needs When Designing a New Medical Device
If you have looked into the steps involved to design and develop a new medical device product, you are likely to have come across the term process validation. It’s an essential term and concept to understand as it helps ensure your design, develop, and then manufacture a product that meets the needs of end-users – … Understanding Process Validation in Medical Device Product Design
