Hello friends
I wondered if anyone could give an example of the level of detail required for Manufacturing procedures / work instructions? How 'high level' can these be to meet 13485 / MDR requirements?
We manufacture class 1 devices (but mainly accessories for devices), and the components used are quite diverse, based on a clinicians requirements (such as different combinations of foam fillers and coverings). Accessory requirements will be written in a drawing sheet produced by a clinician. These may not necessarily constitute 'custom made' accessories; they may for example be a postural support for a wheelchair that has been designed to meet a particular patients' needs, but could 'technically' be used by someone else.
Does anyone have a good example of a clinical device or accessory manufacturing procedure?
Many thanks
James
I wondered if anyone could give an example of the level of detail required for Manufacturing procedures / work instructions? How 'high level' can these be to meet 13485 / MDR requirements?
We manufacture class 1 devices (but mainly accessories for devices), and the components used are quite diverse, based on a clinicians requirements (such as different combinations of foam fillers and coverings). Accessory requirements will be written in a drawing sheet produced by a clinician. These may not necessarily constitute 'custom made' accessories; they may for example be a postural support for a wheelchair that has been designed to meet a particular patients' needs, but could 'technically' be used by someone else.
Does anyone have a good example of a clinical device or accessory manufacturing procedure?
Many thanks
James