Medical device companies have long struggled with understanding design controls and making sure they are implemented correctly to ensure regulatory compliance. Jon Speer Design controls have been a ...
FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...
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 ...
The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...
THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with ...
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