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?
The steerable and deflectable catheter design process helps produce some of the most advanced minimally invasive medical devices currently in use. This includes both diagnostic and therapeutic catheter devices. Furthermore, technology advances mean it is now possible to design advanced catheter technologies that are more complex than ever before. Steerable and deflectable catheters are designed … An Overview of Steerable and Deflectable Catheter Design
The process for bringing your idea for a new medical device from the concept stage through to commercialisation is known as a New Product Introduction, or NPI. The exact steps required will depend on the device you plan to develop. As each marketplace has varying regulatory requirements, where you plan to launch will also influence … The New Product Introduction Regulatory Process for Novel Medical Device Innovations
Intellectual property (IP) is a high priority consideration when designing a new medical device. If you are outsourcing all or part of the development to a third-party contractor, it’s even more important to take steps to ensure your IP is protected. There are many reasons for this, but one of the most important is that … 6 Tips to Protect Your Intellectual Property When Outsourcing Medical Device Design
Arrotek has made a donation to UNICEF’s Get a Vaccine, Give a Vaccine campaign to help the organisation in its efforts to deliver Covid-19 vaccines to the world’s most vulnerable people. UNICEF’s goal is to help vaccinate two billion people across the globe, with a focus on health workers, vulnerable families, and other high-risk groups. … Arrotek Supports UNICEF’s Get a Vaccine, Give a Vaccine Campaign
All medical device design and development projects require effective project management from the start. Watch our video to find out more about our approach to project management here at Arrotek.
