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.
Explore inside a sustainable inhaler - do reusable designs really offer an eco-friendly solution, or is there more to consider than reusability....
Discover how Haughton Design's diverse team leverages their extensive experience to drive innovation in device development. Learn about our expertise and unique insights that ensure successful project...
Explore how commercial constraints influence innovation in businesses. Discover whether budget limits, regulations, and market pressures drive creativity or stifle progress in today's competitive land...
HD strive to foster effective collaboration on all projects to push boundaries in innovation. We discuss how collaboration with the NHS can provide unique insight....
Why do we trust the accuracy of digital devices more than their non-digital counterparts? HD discuss the 'why' and how this improves device development....
We discuss the whether the medical device industry can embrace paper as a viable alternative to plastic as we advance towards Net Zero....
What is the impact of emerging technologies on medical device and product development? Design Engineer, Dan Kirkham, discusses their applications....
We discuss transforming medical device development through the utilisation of interdisciplinary, and cross industry teams....
A pharmaceutical company approached HD to enhance the performance and improve the usability of a Dry Powder Inhaler within a short timeframe and, a tight budget. ...
Pharmapack 2024 was a captivating blend of innovation, collaboration, and foresight. Read our round up of the eco-focused event here....
2023's DDL event brought together industry experts in the field of respiratory health. Here we discuss the latest breakthroughs and innovations....
Should Human Factors as a standalone discipline be made redundant? Design Engineer, Elena, considers this for medical device development?...
Can we achieve the perfect balance of usability, sustainability & connectivity in medical device design? Design Engineer, Rob, considers how....
2023's PDA & PODD conferences provided valuable insight into the drug delivery industry. Here we discuss trends and hot topics from the conferences....
Ahead of the 20th PDA Universe of Pre-Filled Syringes and Injection Devices Conference, we cover where medical device innovations are expected to go....
As the world becomes increasingly connected and user needs constantly evolving, the design of safety critical IFU’s must keep up with this. Design Engineer, Rob, discusses the future of IFU’s, and...