Three Circles has published an updated list of things you need to be aware of about the Medical Device Regulation While the detailed MDR text is of interest to people working within regulatory [...]
A fresh, dynamic approach to designing and developing medical devices
We are an alliance of industry professionals, experienced across the life cycle of medical devices and drug combination products. We provide a smarter product development route to help our clients deliver their medical devices to market efficiently.
The Medical Devices Alliance – The MDA, was born from the vision of a group of companies spanning the sectors of the Medical Devices Industry and University Hospital North Midlands. The alliance is a highly flexible medical device development team, collectively we help our clients to design, engineer and manufacture complex, innovative, products that meet regulatory requirements in the EU and US.
We recognise that identifying, interpreting and meeting the needs of our clients to satisfy patients and healthcare professionals are central to successful products!
By consulting and working as a flexible team our founder members, Haughton Design, Three Circles Consulting, Linki, and UHNM – University Hospital North Midlands can call upon a variety of skills. Our services include; medical device development, project management, human factors engineering, quality system implementation, project quality support and medical device certification.
Our strong relationship with the UHNM R&D team allows us to work closely with consultants and patients in a wide range of hospital based clinical and non-clinical services. This resource allows early consideration of Human Factors into the design process to ensure significantly reduced development times.
Our innovative approach has been developed and tailored to address the need for smarter thinking to reduce the rising cost of UK and global healthcare provision.
We work with Design Controls ISO 13485:2016, Risk Management ISO 14971, Usability ISO 62366 and cGMP (Pharmaceutical Good Manufacturing Practice)