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 ...

Globally, the medical industry is continuously growing and is highly dependent on technological advancements and essential procedures aimed at producing the best treatments. To make sure proper ...

Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. FDA has published and makes available ALL regulations required for medical ...

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 ...

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 ...

South African Health Products Regulatory Agency (Sahpra) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical-device license, with effect from 1 ...