We design, develop and engineer medical devices and new products for clients in the UK, Europe and the USA

HD specialise in developing innovative new medical devices, products, and technology for companies needing to meet the highest standards of regulatory compliance. Our clients include some of the world’s largest companies in the medical device and pharmaceutical 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 medical device or combination product we can work to our own certified ISO: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 can fit seamlessly into your own development process or we can project manage through a full development plan and our own fully traceable ISO systems.

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Services

Learn about the services that will complete projects faster and solve the challenges you face.

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Approach

Learn about our flexibility, how we will approach delivering your project and working with you.

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Projects

Learn more about our past experience, the projects we have delivered, and the sectors we work in.

What We Do

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.

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Meet the Team

At HD we have a superb team of people who appreciate most clients are time poor and are looking for help to move projects forwards quickly. They all have their own areas of expertise, whether that be creativity and idea generation or engineering and manufacturing knowledge. Together, we are a team who can help you.

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Our History

HD was established over 25 years ago by our Managing Director, David Mills. “My background is in design and engineering, HD started mainly in the Automotive and Aerospace sectors with some Healthcare 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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