A clean medical soft-goods manufacturing facility.

FDA Registration vs. ISO 13485 for Sewing Suppliers

When medical device OEMs source sewn soft goods, the compliance question surfaces early: does the sewing supplier need FDA registration, ISO 13485 certification, or both?  The FDA registration vs. ISO 13485 distinction matters because these…







Industrial fabrics and sewn product materials used for equipment cases, tactical bags, and protective covers.

Industrial Fabrics Selection Guide for Sewn Products

Choosing the right fabric for an industrial sewn product involves more than selecting the strongest material available. A fabric that performs well in one environment may fail in another because of abrasion, UV exposure, chemicals,…