This whitepaper outlines in detail the design process required to successfully design a new medical device product, developing it to a point where it can obtain regulatory approval and move into the manufacturing and commercialisation phases. Go to the whitepaper download page. The whitepaper is based on Arrotek’s well-established Six-Step Design Process. This process has … Six-Step Medical Device Design Process Whitepaper
There is a detailed and complex process involved in bringing an idea for a new medical device product from the early concept point through to a stage where it is being used by physicians in real-world clinical settings. The process includes all the typical elements you would find in any product design project. However, there … Arrotek’s Complete Service Offering
Innovation and the medical device industry go hand in hand. At the same time, the industry is impacted by broader challenges, as well as being influenced by the demands and expectations of healthcare professionals and patients. Taking all this into account, what are the trends we should look out for in 2022 and beyond? More … Medical Device Design and Development Trends for 2022
Design for assembly, or DFA, means designing a new medical device product so it can be assembled as easily as possible. It is a crucial part of the design process, particularly as the product moves to the pilot manufacturing, full manufacturing, and commercialisation stages. DFA is a process that applies to medical device products with … What is DFA – Design for Assembly – in Medical Device Design?
We regularly publish blogs, case studies, and other articles on our Knowledge Hub covering various catheter and medical device design topics. Here is a collection of the top blogs of 2021. Catheter Design and Development – Key Considerations to Get Your Product to Market In this blog, Arrotek’s Richard McLoughlin explains the key considerations when … Top Catheter and Medical Device Design and Development Blogs of 2021
Documentation is an essential part of designing a new medical device, getting regulatory approval, and then maintaining compliance while the product is on the market. A crucial part of that documentation is the Design History File (DHF). There is a lot involved in creating and maintaining a DHF file. This blog provides an overview of … What is a Design History File (DHF)?
Multi-lumen catheters are used for several different applications, including highly complicated procedures. They can also be designed with a wide range of performance characteristics. Furthermore, advances in the design of catheter devices are opening up new opportunities and making it possible to create new multi-lumen catheter products that will improve the treatment and diagnosis of … An Overview of Multi-Lumen Catheter Design
Arrotek are delighted and honoured to be shortlisted as one of three finalists in the Irish Medtech Associations Medtech Rising awards 2021 in the category of “Medtech Company of the Year”. We are delighted to be part of this prestigious awards ceremony. The awards annoucement will take place on December 2nd. The entire team at … Arrotek shortlisted as finalist in the Medtech Rising “Medtech Company of the Year” awards
Arrotek strives towards a greener future, and we fully support the move towards environmental sustainability. Work is currently underway to install electric car charging facilities outside of our premises in Finisklin Business Park in Sligo. More of our staff are investing in electric vehicles and this charging point will give them a convenient and hassle-free … Arrotek install Electric Car charging facilities
According to the EU MDR (European Union Medical Device Regulations), medical device manufacturers must, in some circumstances, appoint a European Authorised Representative in order to obtain CE certification for their products so they can be sold in Europe. What is a European Authorised Representative, though? According to the definition in EU regulations, an Authorised Person … What is an EU Authorised Representative, When Do You Need One, and What Do they Do?
