PERKASIE, Pa.--(BUSINESS WIRE)--US BioDesign, a global leader in the production of biomedical textile structure components today announced that they have received their ISO 13485:2003 Certification.
Ocutech, Inc. announced that it has achieved ISO 13485:2016 certification, an internationally recognized standard for quality ...
The medical technology industry has gone through some changes in the last 14 years, as has its regulatory environment, and it was time that ISO 13485 reflected that evolution. The global standard for ...
Hsinchu, Taiwan, Oct. 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 first ...
In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...
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