We realised that saving them time, during both the engagement and development process, is crucial to their own and a project’s success. So, we sat down with a number of clients and consultants to discuss their issues and map out the device development process across the MDR and FDA regulatory requirements.
The result is our new, ISO 13485, Medical Device Development Workflow which meets the requirements if ISO: 13485, FDA 21 CFR 820.30, ISO: 14971, and the regulatory bodies too whilst remaining lean and agile.
Take a look at our introductory video below, and get in touch if you would like to know more.
For many engineers, chartership can be the next logical step in their career once they’ve got a degree and worked as a professional for several years. It has benefits such as recognition of your lev...
At Haughton Design, we’re often asked to step in to save failing projects. Although each project will require a bespoke plan, the following insight into common issues should be helpful to those mana...
The HD team has grown once again! Following our most successful 12 months to date, we have further expanded the team by welcoming Luke Brown who joins as a Design Development Engineer. This week, Luke...
Using FEA can be hugely beneficial to a project as it will typically reduce costs, save time and improve product performance. Further benefits arise with lower environmental impact by using reduced ma...
After completing my A-Levels I didn’t know what I wanted to do as a career, the only thing I knew for definite after many open days was that I didn’t want to go down the typical route of universit...
While our primary aim is to help users lives, it’s important that we help the planet where possible too. We asked the team about some of the challenges faced as well as their discoveries and process...
Human Factors Engineering (HFE), focuses on the interactions between people and devices to minimise use-related hazards and enhance patient safety. Senior Design Engineer, John, and Human Centred Desi...
What is Vacuum Casting, how does it work and how can it benefit the product and medical device prototyping process? The vacuum casting process is very similar to the plastic injection moulding process...
I believe in failing fast: have a really thorough understanding of the assumptions you have made and test these assumptions at the earliest chance possible, usually through prototyping....
A connected medical device is one that forms part of the Internet-of-Medical-Things [IoMT] ecosystem. The IoMT ecosystem facilitates the collection, analysis, and transmission of health data so aims t...
Next in our user series, we chat to Tayla Collinson, a 27-year-old who manages a number of chronic conditions and is currently living with a suprapubic catheter. ...
"Once you ae chartered that is not the end of your education, there will always be new technologies and skills to learn about and apply". This week we chatted to Lead Design Engineer, Jack about his r...
“The more you design things, the more you look at the products around you and wonder how they’ve been made, what the design process must’ve been and question why they designed it like that, and ...
Despite regularly working on a variety of product and medical device projects, there are always improvements to be made and taking the time to really understand user needs is often a crucial piece to ...
This week, Design Manager, Mark shares what attracted him to design & engineering, a typical work week and the biggest challenges he faces in his role as well as insight into the tools he uses to plan...
Developing drug delivery platforms and medical devices can be labour intensive and a frustratingly lengthy process, even for the simplest of devices. Here at Haughton Design, we have worked hard on op...