Meeting the Demands of the MedTech Industry
The MedTech industry is governed by strict regulatory requirements, where quality, traceability, and patient safety are absolutely critical. Products are often used in environments where reliability can be a matter of life and death – placing high demands on both development and manufacturing processes.
To meet these requirements, certification according to ISO 13485 is essential. NOTE is certified to this standard, ensuring that we operate with established procedures for risk management, documentation, and full traceability throughout the entire production chain.
Our customers in the MedTech segment are looking for a partner that can deliver not only high-quality manufacturing, but also expertise in industrialisation, component selection, and lifecycle management – always in compliance with applicable regulations and market expectations.
NOTE offers a comprehensive range of services tailored to medical technology products, including:
· New Product Introduction (NPI)
· Rapid prototyping
· Design for Manufacturability and Testability (DFM/DFT)
· Manufacturing in ISO 13485-certified facilities
· Final assembly in cleanroom environments (when required)
· Documented traceability and validated processes
· Aftermarket services and long-term support
We manufacture everything from circuit boards and subsystems to fully assembled, market-ready medical devices – ready for global distribution
Word from customer
We wanted a long-term partner capable of satisfying our stringent standards of flexibility, proactivity and quality. NOTE´s specialist skills help us right through product lifecycle.
Joakim Wiholm, VP Global Operation & Site Leader Billdal at Unifors Raysafe.
References
Preferred prototype manufacturer for global medical technology company
This company is a global leader in developing, manufacturing and supplying medical devices—NOTE has been providing manufacturing services for this...
Raysafe reduces the unnecessary risk of X-rays
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