Plastics molder and contract manufacturer Marman Industries Inc. (La Verne, CA) announced at last week's MD&M/PLASTEC West trade show in Anaheim that it has been recommended for ISO 13485 certification to perform medical manufacturing in accordance with FDA policies.
Achieving this certification wasn't easy. In fact, Marman started the process several years ago after it inked a contract with a major medical customer in the biopsy/diagnostics industry for manufacturing its products. "We started down the road to our 13485 certification about three years ago, and what a road it's been," commented Dwight Norman, general manager of Marman. "We've had to write procedures for every aspect of our operation, provide constant training to our employees, and even hire a regulatory affairs manager....