Our medical device design development services exist to help you develop your medical devices and new products more quickly. Our focus is on you, our customer, to help overcome the inevitable challenges and problems which arise during the development process.
HD offers three different approaches to meet your project needs:
We can fully control and manage projects for you using our Turnkey approach, or work with your own project managers, under your own QMS, using our Bolt On approach. Either way, we always manage and control our deliverables to suit your own development plan. Once an approach and quality system responsibility is agreed, we will ensure projects progress swiftly and will meet the agreed project milestones.
Our turnkey approach is for clients requiring a complete medical device design and development project delivered through quality management systems for medical devices ISO 13485 or ISO:9001.
The work and project will be compliant with the necessary regulatory requirements for the device or product being developed with a full design data pack, design history file and full traceability of all documentation.
Our system is designed to be flexible so you can enter or leave the process at any point to suit your project needs.
Our bolt-on approach is for clients with their own process, systems and capability but looking for an additional design, development, and engineering team to help complete projects more swiftly.
You may just need a specific task completed or one or two persons amount of time to meet your project’s needs. HD can provide this and deliver it through a whole team, thus adding more value and flexibility to the resource you need for medical device product development.
If required, we will work and support you or your team using your own templates and documentation system to seamlessly integrate our work into your own Quality Management Systems.
Our approach is flexible and designed to make life easier for you. We are experts in designing and developing new medical devices.
Our approach is flexible and designed to make life easier for you. We are experts in new product design, development and engineering.
We can tailor our help and services to suit your needs, we are experts in solving challenging technical problems and designing specialist equipment.
Responsive
We listen to what you want and are here to help you develop medical devices more quickly. We solve problems and challenges.
Flexible
Our approach is flexible and adaptable making it easier to engage with us and meet the needs of your project.
Clarity
Our proposals, planning and project responsibilities are very easy to understand, which reduces risks and saves time.
Traceability
We can work with full design controls and through our software packages provide full traceability for user needs, risk management and documentation.
Trusted
A solid team with fresh ideas, robust design and engineering rigour to ensure medical design and development projects are delivered to agreed time scales and budgets.
HD helps medical device and pharmaceutical companies across the world to develop medical devices faster. Our approach and services are flexible and designed to make life easier for you and your team. If you are looking for more resource or expertise, to quickly pick up a project, solve challenging technical problems or to create a completely new device – then we are here for you.
Whether delivering a full device development project, providing specific design tasks or device development related activities. We help speed up your projects and reduce risk, whilst ensuring full compliance with US, EU and UK regulatory requirements. We can therefore work to our certified ISO:13485 process or work flexibly within your own quality management systems.
Global pharma companies trust us to deliver their drug–device combination products, particularly for parenteral and inhalation drug delivery systems. Many leading MedTech and medical device companies also rely on our medical device design development services to create safe, effective, and compliant products. Clients value our innovative thinking, adaptability, and rigorous medical device engineering standards — all delivered by a collaborative team that’s easy to work with and always ready to help.
Our flexible development approach means you can engage with our medical device development process at any stage. Clear WorkFlow and proposal documents outline project scope, costs, and timelines upfront, providing full transparency so responsibilities and deliverables are clear from the start — reducing risks and ensuring smooth, compliant project delivery.
HD helps companies across the world to develop new products faster. Our approach and services are flexible so designed to make life easier for you and your team. If you are looking for more resource or expertise, to quickly pick up a project, solve challenging technical problems or to create a completely new product – then we are here for you.
Whether delivering a turnkey new product, providing specific stages of work or individual tasks within the new product development process, we will speed up your projects and reduce risk whilst ensuring full compliance with the relevant standards and regulatory requirements.
Global companies trust us to deliver the work they need. Client’s value our fresh thinking, that we are adaptable, have rigorous standards and thorough engineering processes whilst also being easy to work with and always willing to help.
Our unique system is highly flexible so you can enter and leave the development process at any point. Our WorkFlow and proposal documents quickly convey the work we will deliver, the costs involved and a timeline for the activities to be completed. It provides instant clarity, so responsibilities and outputs are obvious from the start, reducing risks and avoiding any misunderstandings as projects are underway.
HD helps companies across the world to develop new technology and equipment faster. Our approach and services are flexible so designed to make life easier for you and your team. If you are looking for more resource or expertise, to quickly pick up a project, solve challenging technical problems or to for a completely new, turnkey project – then we are here for you.
Whether delivering a turnkey new project, providing specific stages of work or individual tasks to get the job done, we will speed up your projects and reduce risk whilst ensuring full compliance with the relevant standards and regulatory requirements.
Not all medical device design development projects are easy to define and some have problems which are difficult to overcome. HD has a proven track record of delivering bespoke design and development solutions. If you need design and development help please give us a call.
Pharma and Medtech companies trust us to deliver medical device design development services and the products they need. Our medical device design development services deliver fresh thinking. We are adaptable, have rigorous standards and thorough engineering processes whilst being easy to work with.
Our unique system is highly flexible so you can enter and leave the development process at any point. Our WorkFlow and proposal documents quickly convey the work we will deliver, the costs involved and a timeline for the activities to be completed. It provides instant clarity, so responsibilities and outputs are obvious from the start, reducing risks and avoiding any misunderstandings as projects are underway.
Ash brings over 25 years of experience in leadership, board advisory roles and hands-on development within the health tech and medical device sectors. He has successfully guided numerous national and international companies through the complete product lifecycle from ideation to full-scale commercialisation and scale-up.
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