If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices … What is an FDA 510(k) Submission
At Arrotek, we ran another virtual Sports and Social Club event during March to promote Spring fitness. We split up into four teams to compete in a challenge to see who could walk, run, and cycle the furthest. Team Carrowmore came out on top covering 931km during the month. Congratulations to them and everyone who … Arrotek Team Covers Over 3,360km in March Fitness Initiative
Take a virtual tour of our medical device design and development facility. To find out more, please email us at [email protected].
You will probably work with a design partner to develop your idea for a new medical device. They will handle the design process, bringing the concept through to the initial prototype and then final prototype stage, ready for you to move to the next stage of your business plan. There are things that you can … Top Tips to Ensure a Successful Medical Device Design Process
Employees in Arrotek have taken part in an Eat Well, Feel Well workshop. It was presented by nutritionist Aoife Clancy. Aoife is the performance nutritionist with Sligo GAA’s Senior football and hurling teams. She also runs a nutrition clinic. The aim of the virtual workshop was to discuss a balanced approach to a healthy lifestyle, … Virtual Eat Well, Feel Well Workshop at Arrotek
Design verification is an important part of the medical device design and development process. It is an element that will be largely looked after by your medical device design partner. However, given it’s important to the overall process, it helps considerably if you have an overview of medical device design verification, why it’s important, and … Medical Device Design Verification – What You Need to Know
A product requirement specification outlines what needs to be achieved during the medical device design process. It is an important step in the process as it ensures design engineers fully understand what is required so they can deliver the best possible product. A good product requirement specification also makes the design process more efficient, and … 3 Essential Tips for Creating a Product Requirement Specification for a New Medical Device Idea
A crucial part of the medical device design and development process is to create a product requirement specification. The creation of this document takes place in the very earliest stages of the process. In fact, in our Six-Step Medical Device Design Process at Arrotek, creating the product requirement specification is one of the primary objectives … Establishing the Product Requirement Specification for Your New Medical Device Idea
Our new video explains how to use the free Arrotek calculator tool to estimate the design and development costs that will be involved to turn your idea for a medical device into a new product. It only takes a few minutes to complete, and you don’t need to provide any commercially sensitive information. Watch the … Video: Estimating the Cost of Designing and Developing a new Medical Device
Medical device design projects require a broad range of expertise as well as established processes and procedures. The project management function and the project manager are central to ensuring medical device design projects run smoothly. Of course, effective project management plays a crucial role in the product design process in other industries too. However, because … The Importance of Effective Project Management for Medical Device Design Projects
