As a design engineering company with expertise in the medical device sector, we understand there are many challenges ahead after we have provided our client with their CAD drawings for a product or component. Medical devices, given the function they perform, are naturally heavily regulated throughout the entire product life cycle. Thus any company brave enough to get involved in this area will have to jump through virtual hoops to keep everything spotlessly clean in order to carry on operating.
During the product development process medical devices are required to be kept clean and free from contamination or dirt. A clean room is a facility utilized for specific industry product design and development and will do just this. In addition, it will likely have additional controls to set humidity levels and hinder air flow. It is therefore vital to assemble medical devices in a clean room and also use it to prepare any prototypes and samples, etc.
There are lots of red tape regulating the classification of a clean room based on how clean the air is, and the number and size of particles permitted per volume of air. The International Organisation for Standardisation ISO13485, is issued to companies who have proven they can assure cleanliness throughout the whole development process. We appreciate the enormity of the task set for all our medical device customers as they navigate their way each time they develop a new product or make changes to an existing one. In a sense, keeping clean to carry on.
