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 ...
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 ...
Abu Dhabi, UAE: ProvenMed announces today that it has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its innovative Med-Tech solutions. “We are ...
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