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.
A brief overview of a busy week… Monday saw my first day working from home. I attended the weekly design review and also learned from Design Development Engineer, Phil Sampey, about HD’s certifie...
A brief overview of a busy week… Monday saw my first day working from home. I attended the weekly design review and also learned from Design Development Engineer, Phil Sampey, about HD’s certifie...
A brief overview of a busy week… Monday saw my first day working from home. I attended the weekly design review and also learned from Design Development Engineer, Phil Sampey, about HD’s certifie...
A brief overview of a busy week… Monday saw my first day working from home. I attended the weekly design review and also learned from Design Development Engineer, Phil Sampey, about HD’s certifie...
A brief overview of a busy week… Monday saw my first day working from home. I attended the weekly design review and also learned from Design Development Engineer, Phil Sampey, about HD’s certifie...
Identifying flaws and validating the mechanical characteristics of a design through physical prototypes and testing procedures can be a lengthy and iterative process for any design team. However, ther...
In a fast-paced environment that requires creativity and daily problem solving it can be easy to forget yesterday’s wins, let alone what’s gone on as we approach twelve months of the pandemic. How...
Following a busy start to 2021, UX Designer, Amber Davies, talks through how the start of a busy year in a design consultancy looks. Design Development Consultant, John, and I also took some time ...
When moving into design development, you should have a feasible concept which can be developed into a product or a mechanism. This is where you might create an alpha prototype, where it should start ...
Prototyping provides value and feedback that is otherwise hard to measure such as proof of concept, technical feasibility, ergonomics, and human factors information. Take ergonomics for example; al...
At HD, we pride ourselves on assembling the best team possible to add extra value to our projects and deliver high quality device or product development solutions. We do this through blending our in-h...
As 2020 came to a close, December also marked 2 months for me at Haughton Design. Despite continued uncertainty with regards to Covid 19 and, approaching a final Brexit negotiation, December was ye...
Identifying flaws and validating the mechanical characteristics of a design through physical prototypes and testing procedures can be a lengthy and iterative process for any design team. However, ther...
Last year, when we published our rundown of 2019 and what we expected from the upcoming year, we don’t think anyone expected anything quite like the 2020 we have all experienced! It has been an unpr...
Amidst another national lockdown, I’ve had a great and hugely insightful introductory week learning the ropes at HD. I’ve had time to get to know my new colleagues, their roles and backgrounds ...
The HD team has grown once again! Following a successful 12 months, and having recently achieved our record month and quarter, we have further expanded the team with Amber Davies who joins us as a UX ...