Medical Device Assembly
We are the contract manufacture specialists for electro-medical device assembly.
We understand the challenges presented by the regulatory and technical demands of the medical device industry and we aim to make life easier by providing our experience and expertise in this field of knowledge.
We work closely with our customers providing engineering expertise during development, documentation support during qualification and best practice clean manufacturing once production commences.
Single Use Disposables
Medical device companies are actively developing an increasing interest in electronics for disposable devices. Disposable devices are designed to be sterilised and used only one time and as a result unit cost can often be reduced by using a wider choice of engineering materials.
Our expertise with material selection for disposable devices has helped several customers to convert their existing reusable devices and make them suitable for the disposable market.
Novara manufacture to the internationally recognised quality management system ISO13485, ensuring that all medical devices which we produce have complete manufacturing traceability. If you are entering the global medical device marketplace, we also have the know-how to assist with your FDA device establishment registration.
We understand that cleanliness is important and we have a ISO 7 classification cleanroom where all of our medical device assembly is undertaken. All of our personnel are required to follow strict procedures and maintain a high level of cleanliness throughout. This gives our customers confidence that bio-burden is kept to a minimum prior to onward processing such as final assembly, packaging or sterilisation.
We have specific experience of which materials are cost effective, bio-compatible and suitable for sterilisation. It’s important to consider material selection early in the design and development phase to prevent more costly changes further into the development cycle.
The use of biocompatible materials is required for patient contacting parts of medical devices, this helps to prevent the use of materials which can cause irritation and sensitisation to humans. Using materials which are tested to the internationally recognised standard ISO10993, helps to minimise the testing required to prove biocompatibility.