Medical device manufacturing at ITL
We offer a turnkey device manufacturing service that spans the entire supply chain from component procurement to distribution, all within a quality controlled environment.
This means that there’s no need for you to incur the infrastructure costs and risks associated with doing everything in-house.
Before you read on take a quick look at our infographic for a comparison of the costs of manufacturing in-house and outsourcing
A combination of automation and skilled manual assembly means that our capabilities extend beyond low volume manufacture, with some projects seeing a throughput in excess of one thousand units per month.
This gives you the opportunity to take advantage of global manufacturing services, supply chains and break into new markets without having to set up a factory yourself.
Our manufacturing services include:
Procurement and Supply Chain Management
As an ITL customer you will benefit from our excellent supplier relationships. We maintain an approved supplier list to ensure that we are always getting the best prices and quality of components.
Our purchasing department can source all, or part, of the materials required for your product, depending on your needs.
Our team of production engineers supervise the transfer into manufacture of all products, whether they were designed and developed by ITL, or by a third party. They are responsible for auditing technical files, creating manufacturing procedures and instructions, process validation (IQ/OQ/PQ) and training production staff.
Assembly and Test
Your medical devices will be manufactured in a dedicated manufacturing workcell which becomes an extension of your company within ITL’s 3,000 m2 factory.
Each cell has assigned staff members, fully approved and controlled work instructions, tools, jigs, fixtures and testing facilities. As quality is key when manufacturing medical devices all products are independently tested by ITL’s best technicians and our Quality Assurance Department according to a mutually defined and agreed “Customer Acceptance” (CA) procedure.
Our Medical device prototyping services incorporate both design and manufacturing. We can manufacture small and larger volumes of prototype medical devices at various stages of development from early ‘looks like’ concepts to fully functioning units for clinical trials.
PCB, Wiring and Cable Loom Manufacture
We manufacture PCB’s in-house using our automated surface mount (SMT) PCB Manufacturing line; this allows us to deliver maximum flexibility regardless of batch quantity, resulting in fast turnaround PCB manufacture and giving us total control of quality and continuity of supply.
Because many medical devices incorporate complex wiring and cable assemblies we also manufacture these in-house using both semi-automatic and skilled manual processes.
We offer PCB manufacturing as a standalone service too, find out more here.
ITL offers complete flexibility in shipping and will ship your product either directly to you or to your end user. We are also able to co-ordinate the logistics of disposables and consumables often associated with medical devices.
Quality Reviews and Scheduling
As a medical device manufacturer, we know how critical it is to ensure that your stock levels, quality control and costs are closely managed. As an ITL client you will have regular quality review and scheduling meetings with our production management team.
We have worked on product development projects for a range of medical and non-medical devices including:
- In-vitro diagnostic devices (IVDs)
- Patient connected medical devices
- Point-of-care diagnostic devices
- Micro camera technology
- Next generation DNA sequencing
- Spectrometer based food safety testers
- Laboratory Instrumentation