Manufacturing your Medical Device
Manufacture of your medical device must be conducted in accordance with the regulatory requirements of your target market. Most commonly and depending on it’s risk class, your device will need to be manufactured in accordance with the requirements of the harmonised standards of ISO 13485:2003 Medical devices - Quality management System- Requirements for regulatory purposes and 21 CFR 820 Quality System Regulation (USA).
Perficio Product Development is able to provide you with guidance and examples of how to establish, qualify and control your product ‘s manufacturing and test system in a compliant and safe manner.
The objectives of establishing a well qualified and controlled manufacturing system match the objectives of establishing an efficient and economical manufacturing system. This is because high yield and low field returns should be a natural consequence of effectively established medical device manufacturing system. The establishment of an effective medical device manufacturing system can only be achieved if the preceding product development activities are conducted in the appropriate manner.