ISO 13485 training course – Quality Management Systems for Medical Devices Training Course Our ISO 13485 training course focusses on the latest ISO 13485 (ISO 13485:2016) standard which is the…
Regulatory Compliance Consulting for Medical Devices in the Asia Pacific Region At PharmOut, we specialize in providing regulatory compliance consulting services to medical device manufacturers and sponsors across the Asia…
Certain medical devices utilize materials of animal origin, and the regulatory requirements are outlined in the ISO 24422-2 standard introduced below. PharmOut regularly assists clients to audit their suppliers of…
Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials. The use of animal material, however, carries the risk of…
What is a Unique Device Identifier (UDI)? Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to: The Unique Device Identifier…
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