Group items tagged

Arazy Group leading medical device consultants in Taiwan offering international standard in achieving market clearance and clinical review clearance for medical devices and equipment in Taiwan under the Taiwan Department of Health (DOH).

Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.