HD specialise in developing innovative new medical devices, products, and technology for companies needing to meet the highest standards. Our clients include some of the world’s largest companies in the medical device, pharmaceutical and manufacturing sectors – they value our desire to help them overcome challenges and complete their projects more quickly.
Our services are designed to make life easier for you and your team. So, using HD will introduce fresh ideas, solve problems and speed up your projects whilst remaining fully compliant with all US, EU and UK regulatory requirements.
If you are looking for a consultancy or development partner to create a new product, medical device or combination product, our approach means we can work to our own certified ISO:9001 & 13485 process or work flexibly within your own QM system to ensure medical device projects are fully compliant with the EU MDR – Regulation (EU) 2017/745 and US – FDA 21 CFR 820.30.
This means our designers and consultants work will fit seamlessly into your own development process or we can project manage through a full development plan using our own fully traceable ISO systems.
Learn about the services that will complete full projects faster and solve the challenges you face.
Learn about our flexibility, how we will approach delivering your project and working with you.
Learn more about our past experience, the projects we have delivered, and the sectors we work in.
Our unique systems are adaptable and flexible to meet your needs. Our proposals will quickly convey the work to be delivered, the costs involved and a timeline for the activities to be completed. Our entire approach provides instant clarity, so responsibilities and outputs are obvious from the start, reducing risks and avoiding any misunderstandings when projects are underway.
Choosing HD means you can quickly add more resource to your team and deal with projects or challenges, through a trusted partner who is able to provide supportive, high-quality advice, and offer pragmatic solutions to get the job done. We are always diligent in our communications, recording the work and activities undertaken during a project. It’s easy for you or your team to know what has been done, and there is full traceability of documentation too.
Valuable IP is captured throughout the process so it is always accessible – IP ownership is transferred to you at the end of the project.
At HD we have a superb team of people who appreciate that most clients are time poor and are looking for help to move projects forward quickly, with minimal risk. Each team member has their own areas of expertise, whether that be creativity and idea generation, human factors, mechanical design engineering, electronics design, or manufacturing knowledge. All are highly knowledgeable with valuable skills learned from medical device development and mechanical design services over the years. Together, we are a flexible design and development team who can quickly help you with ad-hoc work, or a project under full design controls.
HD was established over 25 years ago by our Managing Director, David Mills. “My background is in mechanical design and engineering services, HD started as a design consultancy working mainly in the Automotive and Aerospace sectors with some Healthcare products too. We were soon asked to help with product development, typically in highly regulated sectors, so moving into medical device development was a natural progression”.
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