ISO 13485 does not spell out the specific measures for device manufacturers to take. However, the certification gets people in the mindset that quality happens at every stage of manufacturing and that ...

Hsinchu, Taiwan, October 25, 2017 – The leading custom ASIC company, Global Unichip Corp. (GUC), today announced the achievement of highly coveted ISO 13485:2016 certification, which make GUC the ...

Polymer Medical has achieved ISO 13485:2016 certification, the standard for QMS in the medical device industry.

It’s been less than eight months since Harp and business partner Tom Rybicki launched Polymer Medical Inc ., a plastic ...

Contract manufacturer of wet wipes and sachets Guardpack has announced new funding for expansion into medical device ...

The ISO 13485:2016 and MDSAP certifications, issued to Spark Biomedical by DEKRA, recognize the company as both a developer ...