There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices.
Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system.
NQA has significant expertise in the medical device manufacturing sector and is ideally placed to assist clients to successfully implement ISO 13485 and supporting standards.
To find out more about related Management Standards click HERE.
- Medical Devices (ISO 13485) Factsheet
ISO 13485 is based on the ISO 9001:2008 process model approach and is a management systems standard specifically developed for the manufacture of medical devices.
- Bespoke Solutions Factsheet
NQA provides specialist expertise to help organisations improve performance and manage competitiveness by tailoring its assessment, certification and reporting services.