Two Years with ISO 13485

It has already been 2 years since Assel was certificated with ISO 13485, allowing Customers from the Medical & Healthcare industry to benefit from nearly 40 years of our experience in electronics manufacturing.

Medical & healthcare devices producers have to follow strict regulations of ISO 13485 which also stipulates manufacturing environment to be organized according to certain standards. The standard relates to demanding component selection, strict quality monitoring, precise specification and change management history, as well as product traceability. Today Assel is ready to be outsourcing partner to such companies due to the fact that we can manufacture in line with IPC Class 3 standards with an IPC trainer on-site and we are able to provide unique, self-developed software solutions that allow our Customers to benefit from full visibility and knowledge of each process steps during production of their products and ensure archiving of changes’ history within maintenance of their product specification.

“We always approach each Customer individually and try our best to understand their business objectives in smallest detail and implement them into real life, respectively. To achieve this with Customers within the medical industry, we have had to improve our way of working, look more carefully on our quality, invest in new machines and tighten our management systems. It has been proven that we are in a position to face even most complex projects as we have both – extensive knowledge and modern machinery park.” – says Cezary Małecki, Assel`s Head of Business Development.



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