In order to enter the European medical device market, the quality system meet certain conditions. An effective way to meet these recommendations is to implement a quality system that complies with ISO 13485:2012. This quality systems are the medical version of ISO 9001, designed specifically to help medical device manufacturers comply with relevant European legislation. The standard targets medical device manufacturers. The most recent version (2012) is an update from 2003, with minimal changes.
The building system behind quality
Within a “box in box”system, which is the ISO quality managed, the cleanroom functions as an inside box in a building (the outside box). A common room can thus be transformed into a dust-free ISO 13485 cleanroom environment. This freestanding cleanroom is constructed from metal components. Elements, manufactured to size in advance, are quickly and skilfully assembled on site. This makes projects easier to coordinate and, thanks to its demountable construction, offers maximum flexibility for building modifications, relocation or expansion. This is thanks to revolutionary IFD technology.
Cleanroom “Box in Box” and stand-alone quality system
The Highcare cleanroom is a stand-alone quality system under ISO 13485 with a unique box-in-box set-up which is built under a moveable mezzanine floor. On this intermediate floor, the technical installation is placed, while contaminating equipment ideally remains outside the clean room.
The demountable box-in-box system guarantees constant quality and flexibility within ISO 13485. Thanks to the click-click-ready mode of operation, local repairs and adjustments can easily be carried out, even by in-house personnel, without completely stopping production. The complete cleanroomsystem is made of durable materials of high quality and is completely demountable, movable and reusable without sawing, drilling, filing or painting.