Hi folks
Just wanted some views, as its becoming difficult to determine what is sufficient for the extent of traceability. We are applying the HIE to our 13485 system so we dont need to meet 'full' MDR compliance, but comply with GSPR for our class 3 devices. We make cushions, armrests and similar accessories, mainly for wheelchairs. We have a number of suppliers for different components, such as fabrics, foams, screws and other mass produced parts. We source these from companies that cannot give us full details of the supply chain, but in cases where it matters, they can give us some certification or proof of standards or data sheets (for example, all of our fabrics and foams are fire retardant).
I'm struggling to know how we deal with bolts, screws and washers. We buy these from a company which has ISO 9001, but cannot demonstrate full traceability of the components that we use. However, these components are used for low risk activities, and as such I don't think it is necessary for us to prove full traceability.
Any views on this?
Cheers
James
Just wanted some views, as its becoming difficult to determine what is sufficient for the extent of traceability. We are applying the HIE to our 13485 system so we dont need to meet 'full' MDR compliance, but comply with GSPR for our class 3 devices. We make cushions, armrests and similar accessories, mainly for wheelchairs. We have a number of suppliers for different components, such as fabrics, foams, screws and other mass produced parts. We source these from companies that cannot give us full details of the supply chain, but in cases where it matters, they can give us some certification or proof of standards or data sheets (for example, all of our fabrics and foams are fire retardant).
I'm struggling to know how we deal with bolts, screws and washers. We buy these from a company which has ISO 9001, but cannot demonstrate full traceability of the components that we use. However, these components are used for low risk activities, and as such I don't think it is necessary for us to prove full traceability.
Any views on this?
Cheers
James